Depuy ASR Hip Implant Recall
Latest DePuy ASR™ Hip Implant Recall: August 26, 2010
DePuy Orthopaedics Inc., the orthopedics unit of Johnson & Johnson, announced a voluntary recall of the ASR™ XL Acetabular System (the cup portion of a replacement hip joint) and the ASR™ Hip Resurfacing System (a partial hip replacement in which a metal cap is positioned on the ball of the hip bone or femur). The recall was announced Aug. 26, 2010. More about DePuy Hip Implant Recall
The ASR™ XL Acetabular system has been available, worldwide, since 2004. The ASR™ Hip Resurfacing System is not available in the U.S., but has been sold in other places around the world.
The hip transplant recall is based on early system failures. According to reports, some patients have reported failures within five years of surgery. Hip implants should last about 15 years.
What Causes the Failure?
Patients who have experienced problems with the metal-on-metal hip implants may have experienced problems with the materials. The friction of the metal-on-metal may result in a shedding of debris, which can ultimately lead to inflammation the surrounding tissue. Other problems with the devices have surfaced as well.
For more information about the ASR™ hip implant recall, contact our defective medical device lawyers. We are investigating claims on behalf of people who believe they've; been harmed by one of the recalled devices.
The DePuy ASR™ System
The DePuy ASR™ (articular surface replacements) hip implant, which is no longer on the market, is meant to replace a damaged or diseased hip. The components constitute a system of parts meant to replicate the function of the patient's natural hip.
The natural hip is a ball and socket joint. The ball is a rounded bone at the top of the femur or thighbone. It fits into the socket, which you could compare to a tennis ball cut in half. This shell-shaped hollow half-ball is a part of the hip and is called the acetabulum. To move the hip, the head of the femur rotates within the acetabulum.
Components of the DePuy ASR™ System
The components of the artificial hip attempt to simulate the natural hip in structure and motion. They are the:
- Stem, an elongated metal structure that is inserted into the top of the femur (thigh bone). The stem anchors the implant in place
- Femoral head is a metal ball that is attached to the top of the stem
- Metal insert or liner
- Acetabular cup, or socket, which attaches to the hip and fits over the ball-shaped femoral head within the liner
DePuy ASR™ Hip Resurfacing vs. Hip Replacement
The major reason for hip resurfacing or hip replacement is to allow movement without pain and provide greater range of motion than a diseased joint can.
The ASR™ Hip Resurfacing System (only available outside the U.S. prior to the recall) is for patients who have strong bone density and structure. The reason to do hip resurfacing is to remove the minimum amount of bone around the hip as necessary. Hip resurfacing can be done on the head of the femur only, or on both the femoral head and the acetabulum.
If there are worn hip surfaces, hip resurfacing can help preserve bone by covering worn hip surfaces with metal caps, but this surgery can be more technically demanding for the surgeon than a regular hip replacement. It also requires a larger incision.
A hip replacement involves inserting all of the above components into the patient's hip joint in place of the diseased hip.
DePuy ASR™ Acetabular Cup
The DePuy ASR™ Acetabular Cup or socket began to fail in patients soon after the hip was replaced. Reportedly, the DePuy device stopped working properly within a few years, compared to normal implants, which should last at least 15 years. The DePuy ASR™ cup was shallower than other comparable implants and also was more difficult to insert surgically.
The New York Times reported in a March 10, 2010, article that an Australian study found the implant was failing too early. DePuy had taken the ASR™ off the Australian market in December 2009.
Researchers from a British study also reported problems with metal-on-metal implants. There were adverse soft tissue reactions, occurring most often in patients who had received smaller femoral heads. Patients were having adverse reactions to metal debris that resulted from the friction of the metal-on-metal surfaces. These patients also had higher rates of wear and tear and soft tissue damage.
DePuy ASR™ Recall and FDA Approval
The U.S. Food and Drug Administration (FDA) approved DePuy's ASR™ implant cup and metal ball in 2005. In the autumn of 2009, DePuy stopped distribution of the system worldwide.
DePuy said it had stopped distribution of the system or platform "as a result of declining demand for the ASR™ platform and other market factors." It added that the company would focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.
DePuy ASR™ Failures
The high and early rate of failure of DePuy's platform was compared to the Birmingham Hip Resurfacing (BHR) replacements by researchers from the Joint Replacement Unit at the University Hospital of North Tees in Stockton, England. There were 17 failures or a 3.5 percent failure rate in patients with DePuy's ASR™ platform compared to no failures in the BHR group.
Ask a Lawyer
If you or someone you love has an experience with a hip implant failure, you may qualify to seek compensation for your losses. Our ASR™ hip implant lawyers are available to investigate lawsuits on behalf of injured patients.
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