ASR™ Hip Recall Guide for Patients

professionals recall guide
The guide for healthcare professionals offers clinical detail about the ASR recall and provides help for answering patients’ questions.

Surgeon information

In August 2010, DePuy issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. This recall means additional monitoring and testing may be necessary. 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.

Call the ASR help line
Should you have any outstanding questions please contact the ASR Help Line on 0800 2794865 or 01908 302 195. Lines are open from 09.00 – 17.00, Monday to Friday.

DePuy makes patient safety and health a top priority and is continually evaluating data about its products, including the ASR hip systems. Most ASR hip replacement surgeries have been successful. However, data received by the company showed 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. The data showed 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 voluntarily recalled its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System in August 2010. This recall means additional testing and monitoring may be necessary to check 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.

 
 
 

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 implant brand they have. DePuy encourages patients to check with their surgeon or hospital to determine what brand of hip implant they have received.

learning about your hip replacement

If you had hip surgery after July 2003, please contact your orthopaedic surgeon or the hospital where your surgery took place to determine whether you received an ASR Hip.

If you had hip surgery after July 2003, please contact your orthopaedic surgeon or the hospital where your surgery took place to determine whether you received an ASR Hip.

DePuy does not maintain a list of patients who received an ASR Hip. It may take time for the surgeon or hospital to locate this information for you. For privacy reasons, your orthopaedic surgeon or the hospital where your surgery took place may ask you to request this information in person.

taking the next steps

Once you know what hip replacement you received:

· 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.

· If you do have an ASR Hip – please contact the DePuy ASR Help Line at the number shown above to inform DePuy. This recall means additional testing and treatment may be necessary to check your hip implant is functioning well. DePuy intends to cover reasonable and customary costs of testing and treatment associated with the ASR recall, including revision surgery if it is necessary. 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 out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis.

If you received the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System, you should also request an appointment with your surgeon, who 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.

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.

 
 
 

The hip joint is like a ball that fits in a socket. The socket portion of the hip is called the acetabulum. The femoral head at the top of the thigh bone (femur) rotates within the curved surface of the acetabulum.

With an ASR Hip, a one-piece acetabular cup, which is a metal liner, replaces the acetabulum.

With an ASR XL total hip replacement there are three components: the femoral stem is inserted inside the femur, the femoral head (or ball) connects to the stem and then fits inside the acetabulum. Once the three components are aligned, more natural movement may be restored.

With the DePuy ASR Hip Resurfacing system there are two components: a cap is placed over the natural femoral head and the acetabulum is replaced with the one-piece cup.

All components for the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing Platform are part of this recall.

symptoms

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. If the symptoms continue or come back, it is a sign that there may be a problem.

causes

The symptoms above might be caused by problems 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.

 
 
 

Testing will help your surgeon determine if your hip is working as it should and whether you are having a reaction to metal particles generated by the wear of the components in your ASR hip.

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 order additional blood testing or imaging to check 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 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 System. If such tests show a reaction to the particles, your surgeon may recommend surgery to replace your implant.

paying for testing

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 any necessary testing and treatment including revision surgery if needed, 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 contact the ASR Help Line at the number above.

 
 
 

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 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 any necessary testing and treatment including revision surgery if needed, 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 contact the ASR Help Line at the number above.

 
 
 
Country Region: 
Do not include in the landing page