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
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
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.
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
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
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
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)
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,
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.
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
Biomet that this causes a significant reduction in the implant's strength.3
60 _ process does not require the implant to be
The Biomet PPSTM
heated to extreme temperatures. As a result, the strength of the
40,000 implant is significantly higher than that of implants coated in
40 other fash ions.
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
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.
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.
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.
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
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-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.
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 "
were introduced, most manufacturers moved away from 0 180 ~162'
~ 100 ___
all-metal components. However, newer manufacturing 160
technologies and the desire to improve durability have 140 ______
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.
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 :
\\ I Compresslo
~."'\ I Molded
Direct . n
Cartilage Cartilage ~~
~ .. _,1
..,.,. ", / . II
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
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
to address your condition. All provide the option of minimally
reduces the extent to which the
surgeon must disrupt the soft
tissue surrounding the knee. As a
The Repicci II®: The First Minimally Invasive Knee
result, your muscles, ligaments,
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
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
Shoulder Replacement Humerus
An arthritic or injured shoulder greatly affects
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™
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
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.
Healthy Elbow Arthritic Elbow Total Elbow ImPlant
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.
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.
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?
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.
Primary Cementless Hip Stem Thigh Pain Rates: 10- Year Follow-Up
0000 _14% 25% 10% 36%
30 '" 0 4%
",'.~ :l''0 .:f!'\'-' ~0'0 *''-' '<:'f$ <§ ~'\ ~
0' $' ~'? "<:)0 ~ !l" (Y ~ ,§
'\ 0' 1,? ~0' 0"''' :f,,' .1'r &
2 o0' 0' 0'§ (Y ~
t::::' f$ $ Q,
~ 0 u ~ ~ ,,0<,
Q: Q: " .-,...0
Q: Q,' .~0'
o Biomet o Manufacturer A o Manufacturer C
Primary Cementless Hip Stem Osteolysis Rates: 10-Year Follow-Up
0% 5% 60%
'0 20 55%
o Biomet a Manufacturer A Manufacturer B CJ Manufacturer C
Primary Cementless Hip Stem Failure Rates: 10-Year Follow-Up
ooOO~ 0% 0%
o Biomet o Manufacturer A Manufacturer B r Manufacturer C
Primary Total Knee Failure Rates: 10-Year Follow-Up
3.2% 4% I I
a Biomet a Manufacturer A Manufacturer B o Manufacturer C C1 Manufacturer D
Essential Patient Risk
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
benefits vs. risks associated with total hip replacement and how
they may affect the outcome in your particular case, please consult
POSSIBLE ADVERSE EFFECTS
1. Material sensitivity reactions. Implantation of foreign material in
tissues can result in histological reactions involving various sizes of
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
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)
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
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.
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.
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
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.
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.
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
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
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
Bourne, R.B., et al.: "The Porous Coated Anatomic Total Hip
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