ASR™ XL Acetabular System and
DePuy ASR™ Hip Resurfacing System Recall
Information for Patients
DePuy makes patient safety and health a top priority and is continually evaluating data about
its products. The ASR Hip is one of many hip implants available from DePuy Orthopaedics. Most
ASR hip replacement surgeries have been successful. However, data recently received by the
company shows that more people than expected who received the ASR Hip System experienced
pain and other symptoms that led to a second hip replacement surgery, called a revision
surgery. New data shows that five years after implantation, approximately 12% of patients (1 in
8) who had received the ASR resurfacing device and 13% of patients (1 in 8) who had received
the ASR total hip replacement needed to have a revision surgery.
For this reason, DePuy Orthopaedics is recalling its ASR™ XL Acetabular System and DePuy
ASR™ Hip Resurfacing System. This recall means additional testing and monitoring may be
necessary to ensure your hip implant is functioning well. In some cases patients may need
additional surgery.
If you have received an ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System
(both of which will be referred to as your hip implant), the following information will help you
understand what this recall means to you and the steps you should take.
FINDING OUT IF YOU HAVE AN ASR HIP AND NEXT STEPS
DePuy is recalling the ASR™ XL Acetabular Head System and DePuy ASR™ Hip Resurfacing
System. These systems first became available in July 2003. If you had your hip surgery prior to
July 2003, the hip you received is not subject to this recall. Please speak to your orthopaedic
surgeon about any questions you may have about your hip replacement.
If you had hip surgery after July 2003:
 DePuy is not allowed to maintain a list of patients who received an ASR due to data
protection requirements. Please contact your orthopaedic surgeon or the hospital
where your hip replacement surgery took place to determine whether you received an
ASR Hip. It may take time for the surgeon or hospital to locate this information for you.

For data protection reasons, your orthopaedic surgeon or the hospital where your
surgery took place may ask you to request this information in person.

Once you have this information:
o If you have an ASR Hip, please contact the DePuy ASR Help Line at one of the
numbers listed below to inform DePuy. This recall means
additional testing and treatment may be necessary to ensure your hip
implant is functioning well. DePuy intends to cover reasonable and customary
costs of testing and treatment, including revision surgery if it
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is necessary, associated with the ASR recall. Even if you
do not have out-of-pocket medical expenses, please
contact the DePuy ASR Help Line so that you may be assigned a claim number.
This will allow DePuy to process other reasonable costs, such as lost work time
and travel expenses, subject to review by DePuy.
o If you have not received an ASR Hip, the hip you received is not subject to this
recall. Please speak to your orthopaedic surgeon about any questions you may
have about your hip replacement.
We understand that many patients are concerned by this recall. There are many different
brands of hip implants available and patients may not be aware of what brand of implant they
have. DePuy Orthopaedics encourages patients to check with their surgeon or hospital to
determine what brand of hip implant they have received.
SYMPTOMS, CAUSES AND TESTING
The patients who reported problems in the first five years after their surgery and then had
revision surgery reported a variety of symptoms. These symptoms included pain, swelling and
problems walking. These symptoms are normal if you have just had a hip replacement. If the
symptoms continue or come back, it is a sign that there may be a problem such as:
 Loosening, when the implant does not stay attached to the bone in the correct position
 Fracture, where the bone around the implant may have broken; and
 Dislocation, where the two parts of the implant that move against each other are no
longer aligned
The ASR Hip is made up of ball and socket components that move against each other. These
metal components wear over time and generate very small particles that can only be seen with
a microscope. This is an expected process. These particles do not cause problems for most
patients, but a small number of patients may react to these particles, causing fluid to collect in
the joint and in the muscles around the joint. While this condition may initially be painless, if
left untreated, this reaction may cause pain and swelling around the joint and could damage
some of the muscles, bones and nerves around the hip.
Tests will help your surgeon determine if your hip is working as it should and whether you are
having a reaction to the metal particles. Your surgeon may take X-rays of your hip. Also, a blood
test may be done to indicate the level of microscopic metal particles around your hip. Your
surgeon may also use an ultrasound or an MRI scan to evaluate if you are having a reaction to
the metal particles.
UNDERSTANDING THE ASR HIP RECALL
If you received the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System, you
should schedule an appointment with your surgeon. Your surgeon will be able to evaluate how
your ASR Hip System is functioning.
The “recall” of the ASR Hip does not necessarily mean you will need to have the hip implant
removed. Most people with ASR hip implants do not experience problems. However, it is
important that you follow up with your surgeon on an annual basis for the first five years after
your ASR Hip surgery – even if you are not experiencing symptoms – to ensure that your hip
continues to work well.
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In some cases, your surgeon may order additional blood testing or
imaging to evaluate how your hip is functioning. Your surgeon will
determine the best monitoring plan for you and discuss treatment solutions should they be
needed. If you don’t know who performed your hip replacement surgery, ask your primary care
physician/general practitioner or the hospital where the surgery took place.
WHAT TO EXPECT AT YOUR NEXT SURGEON VISIT
 Your surgeon will evaluate how your ASR Hip System is functioning.
 If you are experiencing pain, difficulty walking, or other symptoms, your surgeon may
want to take x-rays of your hip. X-rays will allow your surgeon to evaluate how the ASR
Hip System is positioned, if there is any damage to the bone and if the ASR Hip System
has remained attached to the bone. If the x-rays show problems with your ASR Hip
System, your surgeon may recommend surgery to replace it.
 Your surgeon may request a blood test to ensure your ASR Hip System is functioning
well.
 The blood test indicates the level of microscopic metal particles around your hip. If the
blood test indicates a high level of these particles, your surgeon may want to do a
second blood test three months later. These levels may be high even if you are not
experiencing any symptoms, so this blood test is very important.
 If the second blood test still indicates a high level of these particles, your surgeon may
want to do an MRI scan or ultrasound scan of your hip. If such tests show a reaction to
the particles, your surgeon may recommend surgery to replace your implant. This is a
decision that you and your surgeon need to discuss based on your own personal health
needs.
 If you do not have any symptoms or test results that suggest you may need to have your
implant replaced, then you should follow your surgeon’s recommendations for
continued follow-up.
 If you do need to have an additional surgery, several options are available and your
surgeon will select the appropriate implant system for you.
PAYING FOR TESTING AND TREATMENT
Your safety and health is important to DePuy, and we do not want cost to be a barrier to
treatment. DePuy intends to cover reasonable and customary costs of testing and treatment if
you need services, including revision surgery if it is necessary, associated with the ASR recall.
By registering with DePuy via the ASR Help Line you will be assigned a reference number which
you should provide at any hospital visits. Please provide hospital staff with the number and
inform them that you are part of the DePuy ASR Hip recall. Any hospital bills will be submitted
to DePuy by your hospital. Any out of pocket expenses should be claimed via the ASR Help Line.
If you have any additional questions Please call the ASR Help Line at the number below or visit
www.depuy.com
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Please check www.depuy.com on a regular basis for additional updates and information.
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