DePuy Hip Implant Manufacturer Recall
Below is a letter from the manufacturer regarding the recall of the DePuy Hip Replacement:
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 System 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™ 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.
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. 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.
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 Hip System. 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.
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