ASR Hip System 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

ASR Hip System recall guide for patients

DePuy Orthopaedics, Inc.(DePuy) has recalled the ASR XL Acetabular Hip System and DePuy ASR ARTICULAR SURFACE REPLACEMENT® Hip Resurfacing System (ASR). This recall means additional testing and monitoring 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
Callers should dial the toll-free number 1800 665 460. The Call Centre will be active from 8.30 am – 5.00 pm, Monday through Friday.

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, Inc. (“DePuy”). 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 them to have a second hip replacement surgery, called a revision surgery. The 2010 Australian National Joint Replacement Registry reports five years after having an ASR hip implanted 7.8% of patients (1 in 13) who had an ASR total hip replacement and 10.9% of patients (1 in 10) who had the ASR resurfacing device needed to have revision surgery. British data shows that five years after having the hip implanted, 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, Inc. has recalled the ASR XL Acetabular Hip System and DePuy ASR ARTICULAR SURFACE REPLACEMENT® Hip Resurfacing System (ASR). We understand that you may be concerned by this recall.
There are many different brands of hip implants available and you may not be aware of what brand of implant you have. DePuy encourages you to check with your surgeon or hospital to determine what brand of hip implant you have received.

 
 
 

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 Orthopaedics 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.

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 had an ASR XL Acetabular System or DePuy ASR Hip Resurfacing System implanted, you should schedule an appointment with your surgeon. Your surgeon will be able to examine you and see how your ASR Hip System is working.

The “recall” of the ASR Hip does not mean that all patients need to have their hip implants removed. Most people with ASR hip implants do not have problems. However, it is currently recommended that you follow up with your surgeon on a yearly basis for the first five years after your ASR Hip surgery – even if you are not having symptoms – to make sure that your hip continues to work well.

In some cases, your surgeon may order other blood testing or imaging, such as x-rays or ultrasound, to see how well your hip is working. Your surgeon will decide the best monitoring plan for you and talk to you about further treatment.

If you don’t know who performed your hip replacement surgery, ask your General Practitioner (GP) or the hospital where the surgery took place and please make a note of the date.

 
 
 

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 you next surgeon visit

Your surgeon will examine you to see how your ASR Hip System is working. If you are having pain, difficulty walking, or other symptoms, your surgeon may want to take x-rays of your hip. If the x-rays show problems with your ASR Hip System, your surgeon may recommend surgery to replace it.

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 follow-up.

If you do need to have another surgery, there are a number of choices available and your surgeon will choose the right implant system for you.

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 testing if you need services associated with the recall of ASR. To assist with this process, Crawford & Company have been appointed to handle such claims on our behalf in Australia. Upon confirmation that you have an ASR implant, we will as far as possible, aim to provide pre-approval for costs and arrange for healthcare professionals to send their tax invoices directly to Crawford & Company for discharge on behalf of DePuy. To do this you will need to call the ASR Help Line on 1800 665 460 to register with the Claims Centre operated by Crawford & Company. You will need to provide some information about your hip replacement surgery which will help us confirm you have an ASR implant. This includes the following:

- The date of your surgery (day, month and year)
- The name of your surgeon
- The hospital where the surgery was conducted

Your surgeon will also need to provide some information to DePuy and we will need your permission to speak with them about your surgery. You will be asked to fill out a form consenting to your medical records being shared with DePuy. You can download a copy of the form from this site or ask the ASR Help Line to send it to you.

When we have confirmed you have an ASR implant we will arrange for Crawford & Company to send you a letter with your ASR Claim number and instructions for healthcare professionals authorising them to send the invoice for their service directly to Crawford & Company for payment.

If you have paid for testing services or you have incurred out-of-pocket expenses associated with testing due to the ASR recall, you can send these bills with evidence of payment to the ASR Help Line and Claims centre for review and processing, quoting your ASR Claims number.

 
 
 

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 follow-up.

If you do need to have another surgery, there are a number of choices available and your surgeon will choose the right 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 treatment if you need services associated with the recall of ASR, including revision surgery if it is necessary. As far as possible we will aim to provide pre-approval for costs and arrange for healthcare professionals to send their tax invoices directly to Crawford & Company. To do this you will need to call the ASR Help Line on 1800 665 460 to register with our Claims Centre. You will need to provide some information about your hip replacement surgery which will help us confirm you have an ASR implant. This includes the following:

- The date of your surgery (day, month and year)
- The name of your surgeon
- The hospital where the surgery was conducted

Your surgeon will also need to provide some information to DePuy and we will need your permission to speak with them about your surgery. You will be asked to fill out a form consenting to your medical records being shared with DePuy. You can download a copy of the form from this site or ask the ASR Help Line to send it to you.

When we have confirmed you have an ASR implant we will send you a letter with your ASR Claim number and instructions for healthcare professionals authorising them to send the invoice for their service directly to Crawford & Company for payment.
If you have paid for services or you have incurred other out-of-pocket expenses associated with testing you can send these bills to the ASR Help Line and Claims Centre for reimbursement quoting your ASR Claims number.

When we have confirmed you have an ASR implant we will send you a letter with your ASR Claim number and instructions for healthcare professionals authorising them to send the tax invoice for their service directly to Crawford & Company for payment.

If you have paid for services or you have incurred other out-of-pocket expenses associated with testing you can send these bills to the ASR Help Line and Claims Centre for reimbursement quoting your ASR Claims number.

 
 
 
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