Joint Replacement Total Hip Replacement.pdf

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					     Joint Replacement
     The technique       of joint replacement        uses                Avascular Necrosis (AVN) Also known                    as

     prosthetic     implants to replace the damaged                      osteonecrosis,      this is a disorder      where the blood

     sections of bone and cartilage            in the joint. The         supply to the bone is compromised,                  causing

     purpose of the procedure          is to restore function            weakness and potential             bone collapse.      Mostly

     and mobility      and to provide     relief from joint pain.        occurring      in people between          the ages of 30 and
                                                                         60, AVN most commonly                affects alcoholics,
     The most common            reason joints are replaced          is
                                                                         people suffering from rheumatoid               arthritis or
     osteoarthritis,    which     is the diagnosis    in 90% of
                                                                         systemic     lupus, and people ingesting             high doses
     patients receiving        a new joint.    However,      patients
                                                                         of steroids.
     may be candidates          for joint replacement        if they

     suffer from any of the following           conditions:              Post-Traumatic Arthritis (PTA) Injuries to the

                                                                         joint and cartilage        which    do not fully heal may
     Rheumatoid Arthritis (RA) This is significantly
                                                                          lead to an arthritic      condition.
     less common        than osteoarthritis,     affecting    2.1
     million     Americans,     mostly women.        Rheumatoid           Paget's Disease A disorder whereby                 bone

     arthritis    is an autoimmune      disease, the cause of            formation      accelerates,    creating    changes in the

     which       is unknown.    The body's immunological                 shape and strength of the bone.

     system attacks healthy tissue, causing                              Descriptions provided by The Arthritis Foundation

     inflammation       of the joint lining and subsequent
     joint damage.




     Total Hip Replacement
     A total hip replacement         removes the arthritic               The implants     are designed to create a new,
     ball of the upper femur (thighbone)             as well as          smoothly     functioning      joint that prevents painful
     the damaged cartilage          from the hip socket. The             bone-on-bone       contact.

     ball is replaced     by a metal or ceramic         ball that        You and your surgeon should discuss various
     is solidly fixed to a stem inserted into the femur.
                                                                         options,    including   the following,      for your
     The socket is replaced with a metal cup, which                      total hip replacement.
     is fixed to the acetabulum,         or socket.




08
                                                                                                                                     ..:




Microplasty® Minimally               Invasive Surgery
Our Microplasty® Minimally    Invasive Instrumentation
reduces the incision from 6-8" to 3-4". This approach
reduces the extent to which the surgeon must disrupt
the soft tissue surrounding the hip. As a result, your
muscles, ligaments, and tendons experience potentially                 Femur
                                                                       (Thighbone)
less trauma during surgery. This may help reduce
post-operative pain, improve your recovery time,
and get you back on your feet faster. Note: your
                                                                                         Healthy Hip
recovery time will depend on your condition, your
compliance to surgeon's instructions, and other factors.



     Potential Benefits of the Microplasty®
     Hip and Knee Program are:
     • Shorter hospital stays
     • Earlier mobilization

     • Accelerated recovery process
     • Less blood loss
     • Reduction    of scar tissue
                                                                                          Arthritic Hip


                                                                                                Acetabular        Component,
Cemented vs. Cement-Free Components                                                             or Socket
In total hip replacement, the femoral component can be
secured to your body in one of two ways: using bone
                                                                                           /       Articulating Surface
cement as a grout to fix the components to your bone, or                                   ~       (Metal, Polyethylene,
using a "cementless" component that is specially designed
to allow your own bone to grow into the surface of the                          .">         ~
                                                                                          .
                                                                                        .~: '     or Ceramic)
                                                                                                     Femoral
implant. Which component your surgeon chooses for you                                 ,~             Component,
will depend on a variety of factors, including the condition                    .itf/.$·        ~    or Stem

of your bone tissue. In the United States, the majority of           Femoral Head,
                                                                            or Ball
patients receive cement-free implants.

                                                                                Total Hip Implant
The Cement-Free Femoral Component, or Stem:
Look for Long-Term Clinical Excellence
Biomet offers several types of cement-free hip stems with over 10 years of published clinical history.
These results generally show that Biomet's hips have performed extremely well, with fewer failures,
less thigh pain, and less implant-related bone loss than other systems with comparable follow-up.            In
fact, the vast majority of hip stems that are currently available from other implant manufacturers have
no published long-term clinical data, due to the fact that these designs have not been used clinically
for very long. Thus, there are no clinical data to indicate the long-term success of these implants.




                                                                                                                               09

                                                                                                                                    II
                  --------------------------------------------------------------------'




     The Femoral Stem: Surface, Strength, and Shape
     Porous Coating Allows              Bone to Grow into the Stem

     For the cementless femoral               component       to be stabilized,   bone must grow

     into the stem. Biomet applies a coating of titanium                    alloy to its cementless
     stems. Using a porous plasma spray known                      as PPSTM,Biomet bombards

     its implants with small titanium                alloy particles,   creating a very rough,
     three-dimensional           coating that allows bone to intertwine            with the

     porous surface. Research has shown that Biomet's titanium                       alloy coating

     is highly biocompatible             and typically       generates the desired ingrowthP

     While     many implant          manufacturers        use a porous coating process of

     some sort, Biomet uses plasma sprayed titanium                      alloy exclusively    on all
     its cementless       stem implants.         Biomet chose the PPSTMprocess because it

     provides       several advantages,         including:




     Implant      Fatigue Strength Comparison
                                                                  Implant Strength - Other methods of coating implants require
                                                                  that the coating and implant be heated to extreme temperatures,
             90~                                                  approaching the melting point of the metal. Research has shown
             80~
                   Biomet                                         that this causes a significant reduction in the implant's strength.3
             70 -63,000
             60 _                                                                process does not require the implant to be
                                                                  The Biomet PPSTM
                                                                  heated to extreme temperatures. As a result, the strength of the
             50 ­
                            40,000                                implant is significantly higher than that of implants coated in
             40 ­                                                 other fash ions.
                                     30,000 30,000
             30 ­
             20 ­                                                 Surface Roughness Promotes a Tight Fit - In order to
             10 -                                                 achieve solid fixation within the bone, the implant must fit tightly
              o                                                   against the bone.4,s A very rough surface, such as that of Biomet's
                                                                  PPS™,creates high friction that "bites" into the bone. As a result of
                                                                  the very tight fit achieved, many surgeons are comfortable getting
                                                                  patients on their feet and putting weight on their new hip implants
                                                                  on the day of, or the day after, surgery. This is called "immediate
                                                                  weight-bearing,"6 a technique surgeons use to help you achieve the
                                                                  fastest possible recovery. The sooner you put your muscles to work,
     The porous plasma spraying process used
     by Biomet retains the highest implant fatigue
                                                                  the sooner you will resume normal activities.
     strength, as compared to other coating methods.3




10
     Shape and Sizing of the Femoral Implant                            <1
     Promotes Excellent Matching
     of Your Anatomy
                                                                           ~                       ~




                                                                           \'r      \ I
     Biomet pioneered the use of tapered stems in total
     hip replacement in the United States.The goal of the
     stem's design and shape is to wedge tightly near the
     top of the femur, reducing the potential for motion
     between the stem and the bone, which can cause
     pain. The inside of the femur in many patients is
     funnel-shaped, and the stem design reflects that
    shape, with the goal of creating a tight fit between
    the bone and the stem.
                                                                           ir  II
    The tapered design and line-to-line fit allow the                            <1=!i>
     stressesof walking and other activities to be
    transferred to the bone. It is important that the bone                     A tapered design and
                                                                               titanium alloy construction
     be stressed as you walk. Bone that is not stressed                        promote appropriate stress
     may atrophy and weaken. Additionally,         Biomet's hip                distribution to the bone.

     stems are offered in a wide range of size increments.
     By providing precise sizing options, Biomet stems
     provide your surgeon with the best chance of
    achieving optimal fit.
                                                                                                             Multiple sizes
                                                                                                             promote optimal fit.




The Acetabu lar Component, or Socket:
Durability and Choice
The femoral stem will be paired with an acetabular                component,

or socket, completing      the "ball-and-socket"       function     of your hip.
The vast majority     of acetabular    components       implanted     in the

United   States are implanted     without     cement and are designed to
help promote    bone in-growth        fixation.   Occasionally,     a surgeon
will use bone cement to affix a socket, depending             on various
factors, including    the patient's condition.

Biomet's RingLoc® acetabular          components       all employ    the

PPSTMporous coating technology,            providing    the benefits of
strength, fixation,   and coating integrity.




                                                                                                                                    11

                                                                                                                                         II
     The Articulating Surface: 'Polyethylene, Metal, or Ceramic?
     Your surgeon has several choices available in articulating surfaces. An articulating surface is where the
     motion of the joint actually occurs.   In    the case of the hip, it is where the head of the femoral component
     meets the acetabular socket. In order to provide smooth motion, the articulating surface must be able to
     withstand certain activities. Currently, polyethylene, metal-on-metal, and ceramic-on-ceramic                  are the most
     common articulating configurations offered. Each has its advantages and its place in the surgeon's repertoire.


                                            Polyethylene: Molded for Optimal Durability
                                                 Polyethylene (plastic) is an excellent material for hip articulation.   It has
                                                  been used in orthopedic implants for decades. Polyethylene, however,
                                                    can wear over time, generating debris in the joint. This debris can
                                                      result in an immunological    reaction known as osteolysis, which can
                                                       result in the destruction of bone tissue and implant 100sening.8
                                                        Not all patients will display osteolysis, even if polyethylene
                                                         wear occurs.

                                                           Newer methods of manufacturing polyethylene components,
                                                            invented and patented by Biomet, have resulted in significant
                                                             intermediate-term   improvements in durability. These
                                                             components, which are made from compression molded
                                                              ArCom® polyethylene, have shown up to 40% wear reduction
                                                              in actual clinical use.9


                                                                Ceramic-an-Ceramic
                                                                Ceramic-on-ceramic     is an option for total hip replacement.
                                                                Manufacturers of ceramic components promote its high
                                                                wear resistance, as demonstrated in laboratory testing.
                                                                 However, there are no long-term data indicating that
                                                                 ceramic-on-ceramic    is more durable clinically than metal­
                                                                 on-metal, another highly durable option.
                                                                There are reasons why a surgeon might elect metal-on­
                                                                metal over ceramic-on-ceramic.      First, ceramic is a glass
                                                                compound, and as such, exhibits different properties than
                                                                metal. While there have been some reports of chipping of
                                                                ceramic compounds reported in orthopedic literature,ll-13
                                                               no such reports have been published on metal-on­
                                                               metal components. The high strength of metal-on-metal
                                                              components also enables the configuration of more implant
                                                             design options than ceramic, which can mean greater range
                                                            of motion and increased stability.


12
                                                 M2a-Magnum'" Hip



Metal-an-Metal: The Choice for More Active Patients                         Range of Motion Comparison         1
Metal-on-metal components have been used and studied in                                 (Maximum Achievable)
orthopedics for over 35 years. When polyethylene components                                  "­
                                                                                      133'

                                                                                                  I~
                                                                             Q)

were introduced, most manufacturers moved away from                0 180 ~162'
                                                                   ~ 100 ___
                                                                       80 __
                                                                             Q)


                                                   120 ___
                                                    en             20­
                                                                   40_ ________
                                                                   60 __
all-metal components. However, newer manufacturing                 160
technologies and the desire to improve durability have   140 ______
                                                                 I

created renewed interest in metal-on-metal components.

Research has demonstrated the following advantages
of metal-on-metal components:

Wear Reduction - In laboratory testing, all-metal
components demonstrated a 99% reduction in wear
over polyethylene components.lO
Design Flexibility:   Large Heads Provide Potentially     Greater
Motion,   Stability - Biomet's metal-on-metal   components, known
as M2a, provide our engineers great design flexibility.     Due to                o
metal's durability, it is possible to make components that accept
large femoral heads. The advantage is that the M2a may provide
greater range of motion than the leading ceramic design.

Large heads also potentially provide greater resistance to dislocation.
The bigger the head, the greater the potential for improved implant
stability at the articular surface. Biomet's newest metal-on-metal
hip system, the M2a-Magnum"; has been carefully designed to
provide maximum range of motion, offering the potential for over
160 degrees range of motion.
The Magnum's'" large range of sizes also allows for better replication of
a patient's anatomy. Only metal-on-metal components allow the largest
heads to be used throughout the entire range of implant sizes. With
polyethylene and ceramic components, patients benefit from larger heads
only among the larger acetabular sockets. No matter what your physical
stature, metal-on-metal will allow you to benefit from large heads.




                                                                                                                   13
                                                                                                                        D/
                                                                                                                         '"
     Knee Replacement
     A total knee replacement is really a cartilage replacement. The knee itself is not replaced, only the
     cartilage on the ends of the bones. The replacement implants include a metal alloy on the bottom of the
     thighbone and polyethylene (plastic) on the top of the tibia and underneath the kneecap. The implant is
     designed to create a new, smoothly functioning joint that prevents painful bone-on-bone contact.

     Your surgeon may elect to replace all or part of your knee, depending on your condition and the extent
     to which your knee is affected by arthritis.




         Femur                                                            Femoral     t      :



                                                                          componen,       Q:S\'
                                                                                            ...
                                                                                          , ~/
                                                                                                                          \\ I Compresslo
                                                                                                                       ~."'\ I Molded
                                                                                                                             I
                                                                                                                               Direct    . n
                                                                                                                               Polyethylene
                                      Healthy                        Eroded
                                      Cartilage                      Cartilage            ~~
                                                                                               :.,
                                                                                               ..
                                                                                                            \•.•.
                                                                                                           ~ .. _,1
                                                                                                     ..,.,. ", /   . II
                                                                                                                        ,

                                                                                                                   "
                                                                                                                   '-'d.O'

                                                                                                                                Tibial


                                                                                               I
                                                                                                 ,.                             Component




                   Healthy Knee                    Arthritic Knee                    Total Knee Implant
                                                                                 (Not Shown: Patellar Component)




        Total Knee Replacement

        Clinical     History:   Excellent Long-Term Results at 10+ Years
        The appendix shows the long-term survivorship of Biomet's AGC® knee system. Biomet also offers newer
        designs that have not been available for as long and thus do not have the same long-term data. All Biomet knee
        replacements are based on the basic design rationale of the AGC®, utilizing the same materials and concepts.


        Materials:     Molded     Polyethylene    Demonstrates      Longevity
        The articular surface of the knee, where the joint motion occurs, relies on polyethylene to reduce friction and
        allow motion. Polyethylene components for the knee are manufactured in one of two ways: direct compression
        molding (OCM) or machined from bar stock. The vast majority of Biomet's polyethylene components for the knee
        are direct compression molded.

        Unlike machining, direct compression molding does not tear at the polyethylene. The machining process can
        result in areas of high stress, which may over time lead to breakdown of the polyethylene. Direct compression
        molding greatly reduces these high stress areas, thus creating a potentially more durable component.14




14
                                      Partial Knee Replacement
Microplasty® Minimally                Surgical Flexibility    and Proven Performance
Invasive Surgery: Reducing            In patients with only limited knee arthritis, surgeons may elect
Trauma to Your Knee                   to perform a unicompartmental     (partial) knee replacement. This
Biomet was the first company to       procedure involves removing and replacing only the diseased
introduce a minimally invasive        portion of the knee, as opposed to resurfacing the entire knee. Not
surgical technique for total knee     all patients are candidates for partial knee replacement. You should
replacement. Our Microplasty®         discuss your condition and treatment options with your surgeon.
Minimally Invasive Instrumentation
                                      Biomet offers the broadest range of partial knee replacements
reduces the incision from 6-8/1 to
                                      available, providing your surgeon with unparalleled flexibility
     Additionally, this approach
3-4/1.
                                      to address your condition. All provide the option of minimally
reduces the extent to which the
                                      invasive surgery.
surgeon must disrupt the soft
tissue surrounding the knee. As a
                                      The Repicci II®: The First Minimally            Invasive Knee
result, your muscles, ligaments,
                                      Replacement Procedure
and tendons will undergo less
                                      Developed in conjunction    with John Repicci, MD, the Repicci II® is
trauma during surgery. This may
                                      a partial knee replacement designed to remove as little bone from
help reduce post-operative pain,
                                      the knee as possible. The entire surgery is performed through a very
improve your recovery time, and
                                      small incision, with minimal trauma to surrounding soft tissue. As
get you back on your feet faster.
                                      a result, Dr. Repicci has reported that many patients leave
                                      the hospital on the day of, or the day after surgery, and
What About Oxinium®?
                                      are back to work within two weeks.15 The Repicci
Oxinium® is a new process,
                                      approach has demonstrated excellent results, with
used by another company, that
                                      a 96% success rate after 5-8 years.16
turns the outside of the knee's
femoral component into a ceramic
                                      The Oxford® Unicompartmental    Knee
compound. While laboratory
                                      System: Now Available in the U.S.
results on wear resistance are
                                      Leading surgeons in Oxford, England,
promising, there are no long-term
                                      along with engineers at Biomet, developed the Oxford®
clinical data on Oxinium®, so no
                                      Unicompartmental     Knee System for partial knee replacement.
one really knows how well it will
work over time.                       It's the only FDA-approved, free-floating meniscal
                                      partial knee system available in the United States and
                                                                                                              I'~
                                                                                                              t'\!
In order to reduce wear in its        has been utilized throughout Europe for more than
knee products, Biomet believes        two decades.
an appropriate engineering step
                                      In a healthy knee, the meniscus serves as a
is to improve the durability of the   shock absorber between the ends of the bones.
polyethylene component. That's
                                      The Oxford® is the first partial implant with an
why Biomet uses direct­
                                      artificial meniscal bearing designed to glide
compression molded polyethylene,
                                      freely throughout the knee's range of motion,
which has been shown to be
                                      more closely replicating normal movement. The free floating
more durable than machined
                                      nature of the device also greatly improves durability of the implant.
polyethylene used by most other
implant manufacturers.18              The Oxford's® long-term clinical results show a 98% success
                                      rate at 10 years, equaling the results of the most successful total
                                      knee replacements.1?
                           ------------------------------------------------------------




                                                                                                       Humeral
                                                                                                       Head
                                                                                                       Component
     Shoulder Replacement                                                                                   Humerus
     An arthritic or injured shoulder greatly affects
                                                                                                       /(upper       Arm)
     activities of daily living by causing pain and limiting
     motion. When shoulder replacement is necessary, the                                     Glenoid
     surgeon may perform either a total shoulder replacement                                 Component

     or a hemi (partial) shoulder replacement. There are two
     main bones involved in shoulder motion: the humeral head

     (rounded portion at the top of the upper arm bone) and the glenoid (cup­
     like bone in front of the shoulder blade). In a hemi (partial) shoulder replacement, the humeral head
     is replaced with a metal implant with the same rounded shape. The glenoid, in this case, is healthy
     and does not need to be replaced. If the glenoid is not healthy, then a total shoulder replacement
     is typically performed. In a total shoulder replacement, the surface of the glenoid is removed and a
     similarly shaped polyethylene component is inserted in its place.

     Another option may be a resurfacing component. This implant is designed to "cap"
     only the top of the humerus.


     Bio-Modular® Total Shoulder
     The Bio-Modular® shoulder system was designed by two leading orthopedic surgeons
     specializing in upper extremity surgery, Dr. David Dines and Dr. Russell Warren. This system
     has been used for over 15 years. The Bio-Modular® shoulder can be used for either a partial
     or total shoulder replacement. Should it become necessary to convert a partial shoulder
     replacement to a total shoulder replacement, the modular design of this prosthesis, along
     with a specialized stem design, facilitates this revision. The Bio-Modular® shoulder system
     offers one of the widest ranges of sizes for each shoulder component. This allows the
     surgeon to more closely match each patient's normal anatomy, which can provide for
     optimal motion and pain relief.


     CopelandT" Minimally Invasive Shoulder Resurfacing                                               Copeland™
                                                                                                      Resurfacing
     The Copeland™ has been implanted since 1986. Since that time, thousands of patients have         Component
     shown remarkable results with this implant. The Copeland™ is unique in that it is the only
     resurfacing device with clinical data going back as far as 17 years.19

     The Copeland™ implant, unlike a total shoulder implant, is designed to cap only the top of
                                                                                                             ~.
     the humerus. The implant requires much less bone and cartilage removal, which makes it
     more conservative than total joint implants. The Copeland™ implant's design and minimally
     invasive approach allow patients to potentially recover more quickly and with less pain. It is
     also potentially less complicated to replace should a future total shoulder replacement become
                                                                                                         Humerus
                                                                                                                    -­
     necessary.


16
  Total Elbow Replacement
  The elbow consists of three compartments (humerus, ulna, and radius) that provide two types of motion.
  The humerus and the ulna allow for hinge-type motion. The humerus and the radius provide rotational
  motion. The joint surfaces are covered by cartilage, providing a cushion between the bones.

  The cartilage can become damaged by various events, including fracture, osteoarthritis, and
  inflammatory or rheumatoid arthritis. When rheumatoid arthritis is present, the cartilage is not being
  provided with enough lubrication and nourishment. This leads to loss of motion and pain in the elbow.




Humerus
                                                                         Ulnar
                                                                         Component


Healthy
                                   Eroded
Cartilage
                                   Cartilage


                                                                        Direct
                                                                        Compression
                                 Radius                                 Molded
                                                                        Polyethylene


            Healthy Elbow                         Arthritic Elbow                        Total Elbow ImPlant




       Discovery'" Elbow
      The Biomet DiscoveryTM Elbow was designed in conjunction with Dr. Hill Hastings II of the Indiana
      Hand Center in Indianapolis and Dr. Thomas Graham of the Curtis National Hand Center in
      Baltimore. The intent was to accurately reproduce the anatomy of the elbow and provide greater
      durability than previous designs. Most elbow implants are made up of a loose hinge mechanism that
      resembles a door hinge with a specified amount of "play" built in to allow for certain types of upper
      extremity movement. The DiscoveryTM incorporates a spherical hinge that effectively spreads out the
      stress over the surface area of the polyethylene portion of the implant. This design allows the surgeon
      to implant the elbow more easily than other designs. It also is designed to minimize wear.




                                                                                                                17

                                                                                                                     I
                  ------------------------------------------------------------~-




Questions about Joint Replacement
Q: Does joint replacement work?
A: After total joint replacement surgery, many patients experience reduced pain, increased

mobility, and improved quality of life. The performance and life span of an implant depends
on many factors, including the patient's presurgical physical condition, anatomy, weight,
activity, and willingness to follow the surgeon's instructions before and after surgery. Surgery
involves potential risks and requires recovery time. Individual results may vary and only an
orthopedic surgeon can determine if surgery is right for you.
Q: What are the possible complications of joint replacement surgery?
A: While     uncommon,       complications      can occur during and after surgery. Complications                     include,

but are not limited      to infection,    blood clots, implant      breakage, malalignment,            and premature          wear.

Infection    and blood clots are two of the complications              that concern      surgeons the most. To avoid these
complications,     surgeons may take various measures, including                  prescribing      antibiotics     and blood               •
                                                                                                                                           ~
thinners before and after surgery. Although            implant     surgery is extremely        successful    in most cases, some

patients still experience      pain and stiffness. Factors such as the patient's             post-surgical       activities   and

weight can affect longevity.        Be sure to discuss these and other risks with your surgeon.


Q: When should I have this type of surgery?
A: Your doctors will decide        if you are a good candidate          for this surgery. Their decision           will   be based

on your medical        history, exam, and X-rays. Your doctors will ask you to decide                   if your discomfort,

stiffness, and disability    justify undergoing      surgery. You and your doctor may decide to delay surgery if
non-operative     methods can adequately           control     your discomfort.



Q: Am I too old for this surgery?
A: Age is not generally      a problem       if you are in reasonably      good health and have the desire to continue

living a productive,     active life. You should see your personal              physician    for an opinion       about your
general health and readiness for surgery.



Q: How long do total joint patients typically stay in the hospital?
A: In the past, a patient could typically         expect to stay anywhere          from 3-7 days, followed            by six weeks

or more of difficult     therapy before returning       to normal activities.       With minimally        invasive surgery, some
surgeons are finding      that patients can be discharged           in as few as one to two days, with significantly
faster return to normal activities        and less post-operative       pain.


Q: What kind of activities can I expect to pursue following joint replacement?
A: That depends on various factors, including                the type of surgery, your health, and your recovery.

Typically,   you should be able to return to certain low-impact                 activities   within   weeks after surgery.
Surgeons generally       discourage      patients from jarring,     high-impact      activities,   such as running        and
stren uous sports.




                                                                                                                                      19

                                                                                                                                           II
                         -------------------------------------------------------------~-




     What Should I Ask My Surgeon Before Surgery?
     If your doctor    recommends    joint replacement,    it is normal to have many questions     about the procedure.
     Below are some of the questions you may want to discuss with your doctor.



     1.   What are the risks and potential complications         of joint replacement?



     2.   How long will the procedure take?



     3.   How long willI    be in the hospital?


     4.   When willI    be able to resume normal activities?



     5.   How much pain relief or increased mobility can I expect?



     6.   Which implant have you chosen for my joint replacement?



     7.   What are the clinical results of the implant system you have chosen?



     8.   What, in your opinion, makes this implant the very best available implant for my condition?




     Appendix
     The following is intended to be a comparison of various manufacturers' products with respect to factors
     influencing joint replacement performance. While every attempt was made to include all relevant sources,
     this is not meant to be an exhaustive comparison of all available literature sources. Other sources may be
     available, particularly those published after the printing of this brochure, and the reader is encouraged to
     make independent inquiries into these sources.

     No statistical analysis was undertaken, and no conclusions regarding the statistical significance of the data
     are drawn. No attempt was made to normalize data on the basis of length of follow-up.      Data were derived
     from independent, peer-reviewed literature and from presentations at public forums, which mayor may not
     have been peer-reviewed.

     Follow-up periods are based on either minimums or averages presented in the references cited. Failure
     rates are based on revisions for reasons other than infection or trauma, if reported; survivorship; or authors'
     comments in the cited reference.



20
                      Primary Cementless Hip Stem Thigh Pain Rates: 10- Year Follow-Up

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                                          o Biomet                                 o Manufacturer A                          o Manufacturer C



                                                                                                                                     ----
                      Primary Cementless Hip Stem Osteolysis Rates: 10-Year Follow-Up

                                                                                                      n
                                                                                                                                      ­
                           0%                                                5%                                                60%
                                                                           9.5%            11%
               0
               U
               t':S60 5%
                      0%
                                                                    7%
                                                                                                      39%

                   30
               '0 20                                                                                                                                        55%
               :0?


               10
                            00001111                                                                   55%




                                                                                                                                                      42%



                                                                                                                                        --I
                                                                                                                                              28.9%




                                                                                                                                       9.2%



                                                                                                                                      T
                                                                                                                                      I




                                      o Biomet                 a Manufacturer A                                    Manufacturer B    CJ Manufacturer C




                                                                                                                                                                  21

                                                                                                                                                                       II
                                        Primary Cementless Hip Stem Failure Rates: 10-Year Follow-Up

                                     16 0000
                                                                                                                                                             16.8%
                                                            2.63%

                 0         u0
                            ~
                           ..•..
                            t';
                                     8
                                     6
                                    10
                                            0%
                           ;:?
                     '"
                      2%
                           4
                           20
                           14
                           12
                                                                                                                       12%



                                                                                                                                                                                  10.1%

                                                                                                             8.6%




                                                                                                      5.7%
                                                                                              5%




                                                                                                                                                                     1%

                                                                              ooOO~                                                          0%         0%




                                                       o Biomet            o Manufacturer      A                        Manufacturer                          B      r    Manufacturer      C




2
     0
     '+-

     0
      QJ
         0
         <I>




         <I>
               U 22
               f<!
               ~8 14
               36 10"0"0
               12
               26
               60
               28
               32
               34
               3
               10
                   24
                   2038
                    16
                    18

                                   4%
                                        Primary Total Knee Failure Rates: 10-Year Follow-Up
                                        5"'



                                        ~
                                                                                                                                                  37%

                                                                                                                                                                                      --­
                                                                                                                                                                                      --­

                                                                                     18%


                                                                                                                                                                                                                II




                                                                                                                              7.4%   8%
                                                                                                                                          10.4%

                                                                                                                                                                                                                I
                                                                                                                       5.9%
                                                                                                                4.9%


                                                                                                      3.2% 4%   I      I
                                                                                                      I
                                                                                           1.9%1.9%

                                                                                                                l
                                                                                                                I




                                    a         Biomet       a        Manufacturer A           Manufacturer                            B                   o Manufacturer       C           C1 Manufacturer   D
    22
                                                                                                                                                                                                                I
Essential Patient Risk
Information
Biomet Orthopedics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, Indiana 46581 USA

The following is general risk information about Biomet joint                 adequate fixation and healing have occurred. Excessive activity,
replacement prostheses. For product-specific risk information,               trauma and weight gain have been implicated with premature failure
visit www.biomet.com.                                                        of the implant by loosening, fracture, and/or wear. Loosening of the
                                                                             implants can result in increased production of wear particles, as we[1
                                                                             as accelerate damage to bone, making successful revision surgery
Biomet Hip Systems                                                           more difficult. The patient is to be made aware and warned of general
                                                                             surgical risks, possible adverse effects as listed, and the importance
The indications, contraindications,    warnings, and possible adverse
                                                                             of fol[owing the instructions of the treating physician, including
effects are discussed below. For further information about the potential
                                                                             follow-up visits.
benefits vs. risks associated with total hip replacement and how
they may affect the outcome in your particular case, please consult
                                                                             POSSIBLE    ADVERSE    EFFECTS
your doctor.
                                                                             1. Material sensitivity reactions. Implantation      of foreign material in
                                                                                  tissues can result in histological reactions involving various sizes of
INDICATIONS
                                                                                  macrophages and fibroblasts. The clinical significance of this effect
You may be a candidate for total hip replacement if your doctor indicates         is uncertain, as similar changes may occur as a precursor to or during
you have any of the following conditions:                                         the healing process. Particulate wear debris and discoloration from
 1. Non-inflammatory degenerative joint disease includingosteoarthritis           metallic and polyethylene components of joint implants may be
    and avascular necrosis.
                                                                                  present in adjacent tissue or fluid. It has been reported that wear
 2. Rheumatoid arthritis.
                                                                                  debris may initiate a cellular response resulting in osteolysis, or
 3. Functional deformity.                                                         osteolysis may be a result of loosening of the implant.
 4. Non-union, femoral neck fracture, and throchanteric       fractures of
                                                                             2.   Early or late postoperative infection, and allergic reaction.
    the proximal femur with head involvement,         unmanageable   using   3.   Intraoperative bone perforation or fracture may occur, particularly
    other techniques.                                                             in the presence of poor bone stock caused by osteoporosis, bone
 5. The need for a revision total hip arthroplasty.                               defects from previous surgery, bone resorption, or while inserting
                                                                                  the device.
Patient selection factors to be considered include: 1) need to obtain pain
                                                                             4. Loosening or migration         of the implants can occur due to
relief and improve function, 2) ability and willingness of the patient to       loss of fixation, trauma, malalignment, bone resorption, or excessive
follow instructions, including control of weight and activity level, 3)
                                                                                activity.
a good nutritional state of the patient, and 4) the patient must have        5. Periarticular calcification or ossification, with or without impediment
reached full skeletal maturity.                                                 of joint mobility.
                                                                             6. Inadequate range of motion due to improper selection or positioning
CONTRAINDICATIONS
                                                                                of components.
You are not to be a candidate for total hip replacement if your doctor       7. Undesirable shortening of limb.
determines that you have any of the following conditions: infection,         8. Dislocation     and subluxation      due to inadequate fixation and
sepsis and osteomyelitis. You may not be a candidate for total hip              improper positioning. Muscle and fibrous tissue laxity can also
replacement if your doctor determines that you exhibit any of the               contribute to these conditions.
following: 1) uncooperative patient or patient with neurologic disorders     9.  Fatigue fracture of component can occur as a result of loss of
who is incapable of following directions, 2) osteoporosis, 3) metabolic          fixation, strenuous activity, ma[a[ignment, trauma, non-union, or
disorders which may impair bone formation, 4) osteomalacia, 5)                   excessive weight.
distant foci of infections which may spread to the implant site, 6)          10. Fretting and crevice corrosion can occur at interfaces between
rapid joint destruction, marked bone loss or bone resorption apparent            components.
on roentgenogram, or 7) vascular insufficiency, muscular atrophy, or         11. Wear and/or deformation of articulating surfaces.
neuromuscular disease.                                                       12. Trochanteric avulsion or non-union as a result of excess muscular
                                                                                 tension, early weight bearing, or inadequate reattachment.
WARNINGS
                                                                             13. Problems of the knee or ankle of the affected limb or contralateral
Biomet joint replacement prostheses provide the surgeon with a means              limb aggravated by leg length discrepancy,         too much femoral
of reducing pain and restoring function for many patients. While these            media[ization or muscle deficiencies.
devices are generally successful in attaining these goals they cannot be     14. Postoperative bone fracture and pain.
expected to withstand the activity levels and loads of normal healthy        15. Metal-on-metal    articulating surfaces have limited clinical history.
bone and joint tissue.                                                           A[though mechanical testing demonstrates that metal-on-metal
                                                                                 articulating surfaces produce a relatively [ow amount of particles,
Accepted practices in postoperative care are important.         Failure          the total amount of particulate produced remains undetermined.
of the patient to follow postoperative care instructions involving               Elevated metal ion levels have been reported with metal-on-metal
rehabilitation can compromise the success of the procedure. The                  articulating surfaces. Because of the limited clinical and preclinical
patient is to be advised of the limitation of the reconstruction and             experience, the long-term biological effects of the particulate and
the need for protection of the implants from full load bearing until             metal ions are unknown.




                                                                                                                                                            23   ~
     Biomet Knee Joint Replacement Prostheses                                       failure of the implant by loosening, fracture, and/or wear. Loosening
                                                                                    of the implants can result in increased production of wear particles,
                                                                                    as we[1 as accelerate damage to bone, making successful revision
     For risk information specific to the Oxford") Unicompartmental      Knee,
     vi sit www.biomet.com/patients/oxford_precaution    s.cfm,                     surgery more difficult. The patient is to be made aware and warned
                                                                                    of general surgical risks, possible adverse effects as listed, and the
     INDICATIONS                                                                    importance of following the instructions        of the treating   physician
                                                                                    including follow-up visits.
     You may be a candidate for total knee replacement if your doctor
     indicates you have any of the following conditions:                            POSSIBLE ADVERSE EFFECTS
     1.   Painful and disabled knee joint       resulting from osteoarthritis,      1.   Material sensitivity reactions. Implantation of foreign material in
          rheumatoid arthritis, or traumatic    arthritis where one or more              tissues can result in histological reactions involving various sizes of
          compartments are involved.                                                     macrophages and fibroblasts. The clinical significance of this effect
     2.   Correction of varus, valgus, or posttraumatic deformity.                       is uncertain, as similar changes may occur as a precursor to or during
     3.   Correction or revision of unsuccessful osteotomy, arthrodesis, or              the healing process. Particulate wear debris and discoloration from
          failure of previous joint replacement procedure.                               meta[lic and polyethylene components of joint implants may be
                                                                                         present in adjacent tissue or fluid. It has been reported that wear
     Patient selection factors to be considered include: 1) need to obtain pain          debris may initiate a cellular response resulting in osteolysis, or
     relief and improve function, 2) ability and willingness of the patient to           osteolysis may be a result of loosening of the implant.
     follow instructions, including control of weight and activity level, 3)        2.   Early or late postoperative infection and allergic reaction.
     a good nutritional state of the patient, and 4) the patient must have          3.   Intraoperative bone perforation or fracture may occur, particularly
     reached full skeletal maturity. Porous coated knee joint replacement                in the presence of poor bone stock caused by osteoporosis, bone
     prostheses have not been approved for non-cemented applications in                  defects from previous surgery, bone resorption, or while inserting
     the United States.                                                                  the device.
                                                                                    4.   Loosening or migration    of the implants can occur due to loss of
     CONTRAINDICATIONS                                                                   fixation, trauma, malalignment, bone resorption, excessive activity.
     You are not a candidate for total knee replacement if you have any of          5.   Periarticular calcification or ossification, with or without impediment
     the following conditions: infection, sepsis, and osteomyelitis. You may             of joint mobility.
     not be a candidate for total knee replacement if your doctor indicates         6.   Inadequate range of motion due to improper selection or positioning
     that any of the fol [owing affect the potential for a positive outcome:             of components.
     1) uncooperative patient or patient with neurologic disorders who is           7.   Undesirable shortening of limb.
     incapable offollowing directions, 2) osteoporosis, 3) metabolic disorders      8.   Dislocation   and subluxation   due to inadequate fixation and
     which may impair bone formation, 4) osteomalacia, 5) distant foci of                improper positioning. Muscle and fibrous tissue laxity can also
     infections which may spread to the implant site, 6) rapid joint destruction,        contribute to these conditions.
     marked bone loss or bone resorption apparent on roentgenogram,                 9.  Fatigue fracture of component can occur as a result of loss of
     7) vascular insufficiency, muscular atrophy, neuromuscular disease, or             fixation, strenuous activity, mal alignment, trauma, non-union, or
     8) incomplete or deficient soft tissue surrounding the knee.                       excessive weight.
                                                                                    10. Fretting and crevice corrosion can occur at interfaces between
     WARNINGS                                                                           components.
     Improper selection, placement, positioning, alignment and fixation             11. Wear and/or deformation of articulating surfaces.
     of the implant components may result in unusual stress conditions              12. Valgus-varus deformity.
     which may lead to subsequent reduction in the service life of the              13. Transient peroneal palsy secondary to surgical manipulation and
     prosthetic components. Malalignment of the components or inaccurate                increased joint movement has been reported fol[owing             knee
     implantation can lead to excessive wear and/or failure of the implant              arthroplasty in patients with severe flexion and valgus deformity.
     or procedure.                                                                  14. Patellar tendon rupture and ligamentous laxity.
                                                                                    15. Interoperative or postoperative bone fracture and/or
     Mala[ignment or soft tissue imbalance can place inordinate forces on               postoperative pain.
     the components which may cause excessive wear to the patellar or
     tibial bearing articulating surfaces. Revision surgery may be required to
     prevent component failure.

     Biomet joint replacement prostheses provide the surgeon with a means           Biomet Elbow and Shoulder Joint
     of reducing pain and restoring function for many patients. While these         Replacement Prostheses
     devices are generally successful in attaining these goals, they cannot be
     expected to withstand the activity levels and loads of normal healthy          DESCRIPTION
     bone and joint tissue.                                                         Biomet manufactures a variety of elbow and shoulder joint replacement
                                                                                    prostheses intended for primary and revision joint arthroplasty for use
     Accepted practices in postoperative care are important.          Failure       in cemented applications.
     of the patient to follow postoperative care instructions involving
     rehabilitation can compromise the success of the procedure. The                E[bow joint replacement components include: humeral and ulnar
     patient is to be advised of the [imitations of the reconstruction and          components, and a hinge component. Components are available
     the need for protection of the implants from full load bearing until           in a variety of surface finishes including: Bond Coat (a thin layer of
     adequate fixation and healing have occurred. Excessive activity,               titanium plasma spray) and Interlok. Sma[1 diameter cement plugs are
     trauma and excessive weight have been implicated with premature                available as specialty components.




24
Shoulder joint replacement components include humeral stems,                  well as accelerate damage to bone, making successful revision surgery
humeral heads, and glenoid components. Components are available               more difficult. The patient is to be made aware and warned of general
in a variety of designs and size ranges for both primary and revision         surgical risks, possible adverse effects as listed, and the importance of
applications. Specialty components include glenoid screws, centering          following the instructions of the treating physician including follow­
sleeves and bipolar heads.                                                    up visits.

INDICATIONS                                                                   PRECAUTIONS

You may be a candidate for surgery if your surgeon determines you have        1.   Patient must avoid placing excessive loads on the implant.
any of the following:                                                         2.   Patient must avoid lifting more than 5 Ibs. with the operated     arm
                                                                                   after surgery.
1. Non-inflammatory degenerative joint disease including osteoarthritis       3.   Patient must avoid putting full body weight on the operated       arm
   and avascular necrosis.                                                         when rising from a seated position.
2. Rheumatoid arthritis.                                                      4.   Patient must avoid sudden or strenuous pulling activities        after
3. Revision where other devices or treatments have failed.                         surgery, as these can produce excessive stress on the operated   arm.
4. Correction of functional deformity.
5. Treatment of acute or chronic fractures with humeral epicondyle            POSSIBLE   ADVERSE    EFFECTS
   (elbow) involvement or humeral head (shoulder), which are                  1. Material sensitivity reactions. Implantation of foreign material in
     unmanageable using other treatment methods.                                 tissues can result in histological reactions involving various sizes
6.   Oncology applications.                                                      of macrophages and fibroblasts. The clinical significance of this
                                                                                 effect is uncertain, as similar changes may occur as a precursor
Patient selection factors to be considered    include:   1) need to obtain       to or during the healing process. Particulate wear debris and
pain relief and improve function, 2) ability and willingness of the              discoloration from metallic and polyethylene components of joint
patient to follow instructions, including control of weight and activity         implants may be present in adjacent tissue or fluid. It has been
levels, 3) a good nutritional state of the patient, and 4) the patient must      reported that wear debris may initiate a cellular response resulting
have reached full skeletal maturity.                                             in osteolysis or osteolysis may result in loosening of the implant.
                                                                              2. Early or late postoperative infection, and allergic reaction.
CONTRAINDICATIONS                                                             3. Intraoperative bone perforation or fracture may occur, particularly
You are not a candidate for surgery if your surgeon determines you               in the presence of poor bone stock caused by osteoporosis, bone
have any of the following: infection, sepsis, and osteomyelitis. You             defects from previous surgery, bone resorption, or while inserting
may not be a candidate for surgery if your surgeon determines that               the device.
any of the following apply to you: 1) uncooperative patient or patient        4.  Infection is a rather common problem in elbow procedures.
with neurologic disorders who is incapable of following directions,           5.  Injury to the ulnar nerve impairment is a major concern in elbow
2) osteoporosis, 3) metabolic disorders which may impair bone                     procedures.
formation, 4) osteomalacia, 5) distant foci of infections which may           6. Loosening, migration, and/or fracture of the implants can occur due
spread to the implant site, or 6) rapid joint destruction, marked bone            to loss of fixation, trauma, mal alignment, bone resorption, and/or
loss or bone resorption apparent on roentgenogram.                                excessive activity.
                                                                              7. Periarticular calcification or ossification, with or without impediment
WARNINGS                                                                          of joint mobility.
Improper selection, placement, positioning, alignment and fixation            8. Inadequate range of motion due to improper selection or positioning
of the implant components may result in unusual stress conditions                 of components.
which may lead to subsequent reduction in the service life of the             9. Undesirable shortening or lengthening of limb.
prosthetic components. Malalignment of the components or inaccurate           10. Dislocation and subluxation due to inadequate fixation, improper
implantation can lead to excessive wear and/or failure of the implant or          positioning, trauma, excessive range of motion, and/or excessive
procedure. Inadequate preclosure cleaning (removal of surgical debris)            activity. Muscle and fibrous tissue laxity can also contribute to these
can lead to excessive wear. Improper preoperative or intraoperative               conditions.
implant handling or damage (scratches, dents, etc.) can lead to crevice       11. Fatigue fracture of component can occur as a result of loss of
corrosion, fretting, fatigue fracture and/or excessive wear.                      fixation, strenuous activity, malalignment,      trauma, non-union,
                                                                                  or excessive weight.
Biomet joint replacement prostheses provide the surgeon with a                12. Fretting and crevice corrosion can occur at interfaces between
means of reducing pain and restoring function for many patients.                  components.
While these devices are generally successful in attaining these goals         13. Wear and/or deformation of articulating surfaces.
they cannot be expected to withstand the activity levels and loads of         14. Accelerated wear of glenoid articular cartilage.
normal healthy bone and joint tissue.                                         15. Intraoperative or postoperative bone fracture and/or postoperative
                                                                                  pain.
Accepted practices in postoperative care are important. Failure               16. Axle or bearing components may disassociate, causing the elbow to
of the patient to follow postoperative care instructions involving                disarticulate.
rehabilitation can compromise the success of the procedure. The
patient is to be advised of the limitations of the reconstruction and
the need for protection of the implants from full load bearing until
adequate fixation and healing have occurred. Excessive activity,
trauma and excessive weight have been implicated with premature
failure of the implant by loosening, fracture, and/or wear. Loosening
of the implants can result in increased production of wear particles, as




                                                                                                                                                            25
                                                                               Bourne, R.B., et al.: "The Porous Coated Anatomic Total Hip
     References                                                                Replacement: A Ten to Fourteen Year Follow-Up Study of a
                                                                               Cement less Total Hip Arthroplasty." J Bone Joint Surg Am, 83:
                                                                               1333-1338,2001.
     1.   Data provided by Biomet testing and other manufijcturers'
          published literature.                                                Burt, e.F., et al.: "A Femoral Component     Inserted Without Cement in
     2.   "Investigational Device Review," Biomet Inc.,                        Total Hip Arthroplasty." JBJS,July 1998.
          September 25, 1986.
     3.   Implant strength reduction: Data on file at Biomet Inc.              Capello, W.N., et al.: "Hydroxyapatite-Coated Femoral Stems in
     4.   Markel, D.e., et aI., "Initial Scratch Fit Stability of Acetabular   Primary Total Hip Arthroplasty: Minimum 1O-Year Clinical and
          Cups: Comparison ofThree Porous Coating Systems," ISTA, San          Radiographic Follow-Up." AAOS Paper 267, March 2001.
          Diego, CA, 1997.                                                     Clohisy, J.e. and Harris, W.H.: "The Harris-Galante      Uncemented
     5.   Alexander, J., et aI., "Choice of Ingrowth Coating Dramatically      Femoral Component in Primary Total Hip Replacement at 10 Years."
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                                                                               Stem." AAOS Poster #PE400, March 2001.
     8.   Schmalzried TP, Kwong LM, Jasty M: "Periprosthetic bone loss
          in total joint arthroplasty. The role of polyethylene wear debris    Hellman, E.J., et al.: "Omnifit   Cement less Total Hip Arthroplasty."
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     9.  Head, W., et al.: "Mechanical Properties and Clinical Evaluation      Hozack, et al.: "Minimum 15-Year Follow-Up With a Collarless,
         of Isostatic Molded ArCom Polyethylene," SICOT, San Diego CA,         Uncemented Femoral Component Made of Cobalt Chrome (Trilock)."
         August 2002.                                                          AAOS Poster #PE353, March 2001.
     10. Data provided by Biomet testing.                                      Inoue, S., et al.: "A 10 to 13 Year Follow-Up Study of Harris-Galante
     11. Bierbaum, B.E., et aI., "Ceramic-on-Ceramic  Bearings in Total        Type Prosthesis in Total Hip Arthroplasty." J Orthop Sci, 5(6): 561-6,
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     12. Garino, J.P., "Modern Ceramic-on-Ceramic Total Hip Systems            Kim, YH., et al.: "Primary Total Hip Arthroplasty with the AML Total
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     13. Hasegawa, M., et al.: "Ceramic Acetabular Liner Fracture in           Total Hip Arthroplasty in Patients Under Fifty." AAHKS 8th Annual
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                                                                               patients." Journal of Arthroplasty, April, 16(3): 312-6.
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          pp.512-518.                                                          No.5, August 2003.

                                                                               Rothman, R.H., et al.: "1 O-Year Minimum Follow-Up With a
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                                                                               Different Cementless Tapered Stems." Clin Orthop, (393): 121-7,
                                                                               December 2001.




26
    Sakalkale, D.P., et al.: "Minimum 1O-Year Results of a Tapered               Hartford, J., et al.: "Mobile    Bearing Total Knee Arthroplasty." AAOS
    Cementless Hip Replacement." CORR, May 1999.                                 PE455, March 2001.

    Xenos, j.S., et al.: "Porous-Coated Anatomic Total Hip Arthroplasty at       Hoffmann, AA, et al.: "Ten to 14-Year Clinical Follow-Up of the
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    Xenos, J.S., et al.: "The Porous-Coated Anatomic Total Hip Prosthesis,       Huang, eH., et al.: "Long-Term Results of Low Contact Stress Mobile­
    Inserted Without Cement." JBJS,january 1999.                                 Bearing Total Knee Replacements." CORR, November 2003.

                                                                                 Laskin, R.S.: "The Genesis Total Knee Prosthesis." CORR, July 2001.
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                                                                                 Lidgren, L., et al.: "Annual Report Swedish Knee Register." November
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                                                                                 Condylar Prosthesis." JBJS,March, 1995.
    Berger, R.A.: "Long-Term Follow-Up of the Miller-Galante       Total Knee
                                                                                 Mason, M.D.: "10- to 14-Year Review of a Non-Constrained,         Cruciate
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                                                                                 Retaining, Total Knee Arthroplasty."     Orthop Transactions, 17:1091, 94.
    Berry, D.J., et al.: "Total Knee Arthroplasty with the Cruciate-Retaining
                                                                                 Meding, J.: "Total Knee Arthroplasty with 4.4mm of Polyethylene:
    Kinematic Condylar Prosthesis." AAHKS 9th Annual Meeting,
    November 1999.                                                               Average lO-Year Follow-Up." 32nd Hip Society, Boston,
                                                                                 Massachusetts, September 2000.
    Brassard, M.F., et al.: "Does Modularity   Affect Clinical Success?"
                                                                                 Parker, D.A, et al.: "Long-Term Follow-Up of Cementless vs. Hybrid
    CORR, July 2001.
                                                                                 Fixation for Total Knee Arthroplasty." CORR, July 2001.
    Buechel, F.F.:"Cementless Meniscal Bearing Knee Arthroplasty:        7- to
                                                                                 Ranawat, E.S., et al.:, "Long-Term Results of the Total Condylar Knee
    12- Year Analysis." Orthopedics, September 1994.
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