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DePuy ASR™ Articular Surface Replacement

and ASR™ XL Acetabular System Recall

Pack Contents:

Health Care Professional Letter (DPY8)

Urgent Field Safety Notice (DPYOUS2)

Patient Letter – Draft (DPY9)

Information for Patients (DPY10)

Patient Consent Form (DPYOUS12)


Health Care Professional Letter

August 24, 2010

ATTN: DePuy Customers

I am writing to share urgent and important information about DePuy’s decision to voluntarily
recall the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. (Note:
The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S.
and the ASR™ XL Acetabular System was available worldwide.) The official recall notice is
attached.

Most ASR hip replacement surgeries have been successful. However, data recently
received by DePuy shows that more people than expected who received the ASR hip
require revision surgery.

For this reason, DePuy Orthopaedics is voluntarily 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 patients’ hips are functioning well. In
some cases, patients may need revision surgery.

Our goal is to help you answer your patients’ questions and support their prompt follow up
care and treatment. Please contact your patients and request that they schedule a follow
up appointment for evaluation.

Included with this letter are several documents that you may use to communicate with
patients, including:
--Sample patient cover letter
--Information for Patients
--Medical Release Form

The recommended patient follow up protocol is that patients with radiographic changes
indicative of product failure should be treated according to normal procedures. All other
patients should be followed according to the April 22, 2010 and the May 25, 2010 UK
Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.1, 2

Per the April 22, 2010 Device Alert, a small number of patients may develop progressive
soft tissue reactions to metal wear debris without exhibiting any symptoms. The debris can
cause soft tissue damage which may compromise the results of the revision surgery. Early
revision of poorly performing hip replacements that generate metal debris should give a
better revision outcome, so metal ion testing is extremely important. Therefore, metal ion
testing should be considered in cases where the surgeon is concerned about the hip
replacement even if the patient is asymptomatic.

It is important to note that DePuy intends to cover reasonable and customary costs of
monitoring and treatment for services, including revisions, associated with the recall of ASR.
Diagnostic testing, as recommended by the MHRA, may be used when you have concerns
about a patient with the ASR System, even when they’re asymptomatic. The procedure for
the reimbursement process will be provided to you at a later date, but fees for services
should first be submitted to payors in the usual manner and DePuy will then reimburse
patients and payors for out of pocket reasonable and customary expenses.

Document ID: DPY 8


Reimbursement is subject to the completion and submission of required documentation to
DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the
patient has an ASR component implanted and has consented to provide DePuy with x-rays,
explants and any other requested medical information after the revision surgery.

The completion of the patient release form will allow you to share information about this
patient’s case with DePuy and will allow DePuy to provide information directly to patients
regarding the ASR Hip System. DePuy will also use this information to process claims
efficiently and to help DePuy to better understand the causes of the problems with the ASR
Hip System. Patients should complete the form and bring it with them to the appointment.

We will provide you with a brief form to be completed for each patient, including date of
surgery, components implanted, follow up status and the results of any metal ion testing.
We appreciate your assistance with this process, and we will provide compensation at a
rate of $50 per patient for each completed form that is submitted to DePuy.

You can access the latest information about the recall by visiting our website at
www.DePuy.com. If you have additional questions, please contact the physicians listed
below:

U.S./Canada/Latin America
Rodrigo Diaz, Scientific Information Officer, 574-372-7401
Mikhail Chkolnik, Project Leader, Clinical Research, 1-888-554-2482

EMEA
Jens Krugmann, Director Product Safety and Risk Management, +353 87 6123 872
Dirk Parwis Ghadamgahi, Manager, Customer Education, +49172 446 6209
Greg Medalla, Manager Clinical Research, +44 113 387 7017

ASPAC
Aran Maree, Vice President Strategic Medical Affairs, +65 6827 6015

Thank you for your assistance during this recall process.

Sincerely,

Pamela L. Plouhar, Ph.D.


VP, Worldwide Clinical Affairs

Document ID: DPY 8


DePuy International Ltd
Number One
White Rose Office Park
Millshaw Park Lane
Leeds LS11 0EA
Tel: +44 (0) 113 3877800
Fax: +44 (0) 113 3876087

August 24, 2010


URGENT FIELD SAFETY NOTICE

DePuy ASR™ Articular Surface Replacement and ASR™ XL Acetabular System


Type of Action: Removal of devices from the market (Recall)
FSCA Identifier: DINT 12725
Model number: All implant components of the ASR platform (see attached)
Batch / lot number of affected devices: All lots

Dear Clinicians:

As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data
from a variety of sources including national joint replacement registries, published literature, company
sponsored clinical trials, internal complaints data and unpublished clinical research reports.

DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK
that demonstrated the ASR™ System had a higher than expected revision rate at 8-9 percent at three
years when used with smaller head sizes (less than 50 mm diameter). The overall revision rate for
ASR continued to be in line with the class of metal-on-metal monoblock systems based on the data
available to DePuy at that time.

DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of
England and Wales. The data shows the five year revision rate for the ASR™ Hip Resurfacing System
is approximately 12 percent and for the ASR™ XL Acetabular System is approximately 13 percent.
These revision rates are across the entire size range. The risk for revision was highest with ASR head
sizes below 50 mm in diameter and among female patients.

Because the new NJR data shows a higher than expected revision rate at five years, DePuy is
issuing a voluntary recall of all ASR products.

Reasons for revision identified within the datasets are consistent with those previously reported for
ASR and include component loosening, component malalignment, infection, fracture of the bone,
dislocation, metal sensitivity and pain.

Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the
ASR™ XL Acetabular System was available worldwide.

Actions
Please share this notice (Document ID: DPYOUS2) with your organization and any organization
where the ASR products may have been transferred. Do not implant the ASR devices. Your
DePuy representative will assist with returns of any remaining inventory.

Patient Follow Up
Patients who received the ASR System should be informed of this recall and instructed to return for a
follow up visit.

Document ID: DPYOUS2


Patients with radiographic changes indicative of product failure should be addressed according to
normal procedures. All other patients should be followed according to the April 22, 2010 and the May
25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.1, 2 Per the
April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions
to metal wear debris. The debris can cause soft tissue damage which may compromise the results of
the revision surgery. Early revision of poorly performing hip replacements that generate metal debris
should give a better revision outcome. Therefore metal ion testing should be considered in cases
where the surgeon is concerned about the hip replacement. The May 25, 2010 Alert specifies the
following actions specific to the ASR:
Follow up all patients implanted with ASR acetabular cups at least annually for five years
postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45°, particularly
where a small component has been implanted:
o Consider measuring cobalt and chromium ion levels in whole blood and/or performing cross
sectional imaging including MRI or ultrasound scans
o If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either
metal ion, a second test should be performed three months after the first in order to identify
patients who require closer surveillance, which may include cross sectional imaging
o If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses,
then revision surgery should be considered.

Financial Support for Patient Follow Up


DePuy Orthopaedics intends to cover reasonable and customary costs of monitoring and treatment for
patients who might need such services associated with the recall of ASR.

Diagnostic testing, as recommended by the MHRA, may be used when surgeons have concerns about
a patient with the ASR System. If, based on patient symptoms and/or the results of the diagnostic
testing, the surgeon recommends a revision procedure, DePuy will provide this reimbursement.

Reimbursement is subject to the completion and submission of required documentation to DePuy to


confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR
component implanted and has consented to provide DePuy with x-rays, explants and any other
requested medical information after the revision surgery.

Transmission of this Field Safety Notice


This notice needs to be passed on to all those who need to be aware within your organisation or to
any organisation where the potentially affected devices have been transferred.

If you require additional information regarding this matter, please contact the DePuy Vigilance
Manager on +44 (0)7771 971930. For clinical questions, please contact the following physicians:
Jens Krugmann, Director Product Safety and Risk Management, +353 87 6123 872
Dirk Parwis Ghadamgahi, Manager, Customer Education, +49172 446 6209
Greg Medalla, Manager Clinical Research, +44 113 387 7017

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has been made aware of this
matter.

Sincerely,

Pamela L. Plouhar, Ph.D.


VP, Worldwide Clinical Affairs

References:
1. Medical Device Alert: All metal-on-metal (MoM) hip replacements. http://www.mhra.gov.uk/ Publications/
Safetywarnings/MedicalDeviceAlerts/CON079157
2. Medical Device Alert: DePuy ASRTM acetabular cups used in hip resurfacing arthroplasty and total hip replacement.
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON082089

Document ID: DPYOUS2


Patient Letter

August xx, 2010

Dear ______,

I am writing to share important information about your hip replacement implant, the
DePuy ASR Hip System. A small number of patients with the hip implant you received
have experienced problems that require additional care and potentially further treatment.
For this reason, DePuy Orthopaedics, Inc., the maker of your hip, has advised me that
they are recalling the ASR Hip System and recommending that patients be evaluated.

Please call my office to schedule an appointment for the evaluation of your hip. During
that appointment, I would like to discuss with you any symptoms/problems you are
having, additionaI testing that has been recommended and the best plan for ongoing
testing and treatment for you. DePuy will pay for the examination and any medical
follow up as described in the attached Information for Patients sheet.

The Information for Patients sheet, provided by DePuy, will help to address any
questions you may have about your hip implant, the reason it is being recalled and what
you need to do. If you have any questions regarding the performance of your hip implant,
please contact my office. If you have questions about payment for treatment, please
contact DePuy using the phone number included in the Information for Patients sheet.

Also included with this letter is a Medical Release Form. Your completion of this form
allows me to share information regarding your hip with DePuy. It is important to share
this information with DePuy so that DePuy may contact you directly regarding any
additional information regarding the ASR Hip System and process your claims efficiently.
Please complete the form and bring it with you to your next appointment.

Once again, please contact my office as soon as possible to set up a follow up


appointment so that I may address your concerns and discuss the best treatment
options for you.

Sincerely,
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. 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 experienced pain and other symptoms that led to a
second hip replacement surgery, called 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.

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.

If you have received an ASR Hip Replacement or 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.

WHAT HAPPENS TO THE ASR IMPLANT AND WHAT SYMPTOMS SHOULD I


WATCH FOR?
The patients who reported problems in the first five years and 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. But 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 right
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.

Your hip implant is made up of ball and socket components that move against each
other. These components are made of metal that wears over time and generates very
small particles that can only be seen with a microscope. This is an expected process.
Different people respond to the particles in different ways. 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.

August 24, 2010


There are tests that will help your surgeon determine if your hip is working as it should
and if you are having a reaction to the metal particles. Your surgeon may take x-rays of
your hip. Also, a blood test can be done to indicate the level of microscopic metal
particles around your hip. Your surgeon may also use an ultrasound or MRI to evaluate
if you are having a reaction to the metal particles.

WHAT DOES THE RECALL MEAN FOR ME?


Please contact the surgeon who performed your hip implant to determine if you received
the ASR System. Most people with ASR hip implants do not experience problems.
However, it is important that you follow up with your surgeon on a annual basis for the
first 5 years after your ASR hip surgery – even if you are not experiencing symptoms –
to ensure that your hip continues to work well. 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 or the hospital where the surgery took place.

DePuy Can Help: If you are unable to determine the type of hip implant you received,
we can help. Please fill out the release form available on www.DePuy.com.
U.S. patients should mail a completed form to DePuy Orthopaedics, Customer Quality
Department, PO Box 988, 700 Orthopaedic Drive, Warsaw, IN 46581.
Patients outside of the U.S. should mail a completed form to DePuy International
Limited, Complaints and Vigilance Department., St. Anthony’s Road, Leeds, LS11 8DT.
This will allow DePuy to contact your surgeon or hospital on your behalf.

If you received the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing
System, you should take the following steps:

Schedule an appointment with your surgeon. Your surgeon will be able to


evaluate how your ASR hip 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 is positioned, if there is any damage to the bone and if the ASR
hip has remained attached to the bone. If the x-rays show problems with your
ASR hip, your surgeon may recommend surgery to replace it.

In some cases, your surgeon may order additional blood testing or imaging to
ensure your ASR hip is functioning well.

The evaluation may include a blood test that 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 testing is very important.

If the second blood test still indicates a high level of these particles, your surgeon
may want to do an MRI or ultrasound test of your ASR hip. If such tests show a
reaction to the particles, your surgeon may recommend surgery to replace your
August 24, 2010
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.

WHO WILL PAY FOR MY 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, associated with the recall of
ASR. Bills for services should first be submitted to your insurance company or Medicare
in the usual manner and DePuy will then reimburse you for your out of pocket
expenses. Detailed information about the reimbursement process will be available
shortly. Please visit our web site at www.depuy.com or call the ASR Help Line at the
number below.

WHO CAN I SPEAK WITH?


We recommend contacting your orthopaedic surgeon directly.

DePuy Can Help:


Additional questions? We are here to help. Do not hesitate to call the DePuy ASR Help
Line beginning August 27, 2010.

Patients in the U.S. and Canada: Callers from the U.S. and Canada should dial the
toll-free number 888-627-2677. The U.S. and Canada call center will be active from
8 a.m. to 9 p.m. EST.

Patients outside of the U.S.: Please secure an operator and instruct them that you
need to place a collect call to the United States at 813-287-1651. The operator will
make the connection and transfer you to a representative who will greet you in English.
Please respond in your preferred language to the representative. You will be transferred
to a translator who speaks your language. The transfer to the translator may take up to
two minutes. DePuy appreciates your patience while the call is being transferred. The
OUS call center will be active 24 hours a day, 7 days a week.

Additional information is also available at www.depuy.com.

Please check depuy.com on a regular basis for additional updates and information.

August 24, 2010


Patient Consent Form
(for disclosure of records)

DEPUY ASR™ HIP RESURFACING SYSTEM AND


ASR™ XL ACETABULAR SYSTEM

Patient Name:
Patient Address:

Patient Date of Birth:

Information about you and your health is sensitive and confidential and normally will
not be disclosed to anyone outside the hospital without your express consent, or at
your request.
In the context of the review it is important for the manufacturer of the DePuy ASR™
Hip Resurfacing System and ASR™ XL Acetabular System (“ASR Products”),
DePuy International Limited, to be kept fully informed regarding the review process
and, in particular, that they be advised of any cases of implant failure or otherwise.
Persons/organizations receiving the information:
DePuy International Limited
Complaints and Vigilance Dept.
St. Anthony’s Road
Leeds, UK, LS11 8DT
1. I consent to the following being provided to DePuy International Limited:
i. All my medical records and x-rays relating to my original implant surgery of
an ASR Product on/or about ____________, to include but not be limited
to:
Discharge Summary, physician progress notes; physician orders,
operative/procedure records and reports; emergency room record, (if
applicable); radiographs; product code and lot number of components
used, and all records relating to the surgery and all follow up visits and
records.
ii. All such medical records and x-rays relating to my subsequent revision
surgery that occurred in/or about ____________.

iii. The ex-planted ASR product component(s), if available, in respect of both


my original implant surgery and subsequent revision surgery, to enable
DePuy International Limited to carry out tests upon such components.
2. I confirm that the process by which my medical records and my ASR Product
component(s) will be reviewed including the information that will be asked of
me has been fully explained to me. I have read and understood the patient
clinical review form (or title of form). I have had the opportunity to ask
questions and my questions have been answered to my satisfaction.
3. I consent to DePuy International Limited using personal information about my
health collected by this review for analysis. I also consent to this information
being passed to DePuy International’s sister company DePuy Orthopaedics,
Inc. of Warsaw, Indiana, USA.

Signature of Patient or Patient’s representative Date


Consent Form Document ID: DPYOUS 12