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ASR Hip Replacement Recall

Hip replacements are prosthetic devices designed to help people whose mobility is hampered by pain or disability in their hip. A hip replacement is supposed to last for upwards of fifteen years. However, many hip replacements suffer early failure, and may contribute to more general, even systemic problems. One of these hip replacements that suffered a high failure rate is the ASR, manufactured and marketed by DePuy Orthopaedics, a division of Johnson & Johnson. On August 26, 2010, DePuy Orthopaedics initiated a voluntary recall of two ASR models after data from several countries indicated they had a higher-than-expected failure rate.

If you or a loved one has suffered a premature failure of an ASR hip replacement, you may need to have a second surgery and you may be able to receive compensation for this. Contact your doctor as soon as possible to see if you need surgery. To learn more, please contact the product liability lawyers at Jacoby & Meyers Law Offices today for a free initial consultation.

About the ASR Hip Replacement Systems

The ASR is a system for providing partial or total replacement of the hip joint. The hip joint is a ball-and-socket joint composed of two parts: the ball of the femur, the long bone in your leg that runs from the hip to the knee, and the socket in the pelvis, called the acetabulum. There are three different models of the ASR system:

  • ASR Hip--a metal cup that replaces the acetabulum
  • ASR Hip Resurfacing--two metal cups, one that fits inside the acetabulum and one that fits over the ball of the femur
  • ASR XL Acetabular System--consists of three parts: the acetabular cup, the femoral ball, and a stem that fits inside the femora and attaches to the ball

The recall only affects the Hip Resurfacing and XL models of the ASR. The Hip Resurfacing model was never approved for use in the US.

The Cause of the Hip Replacement Recall

There have long been concerns about the ASR hip replacement systems, but the initiating event for this recall was data from the National Joint Registry (NJR) of England and Wales, which suggested that the implants had a higher-than-expected failure rate. Although hip replacement prosthetics are supposed to last an average of fifteen years, the NJR data showed that 12-13% of the ASR units failed within five years. The NJR data was the second set of national registry data to show problems with the ASR. The first data came from Australia, where the high failure rate led DePuy to voluntarily withdraw the ASR from the market in December 2009. However, the company is not yet admitting that these might be considered defective medical devices.

Delayed Recall for Hip Replacement

Although concerns about the ASR have been voiced publicly since at least 2008, DePuy did not initiate the recall until after the company had already decided to phase out the system due to declining sales--announced late in 2009--and after it issued a public warning to doctors and patients about the likely failure of the device. Over 300 reports of device problems were reported to the FDA in 2008 and 2009, and over 90% of these reports involved replacement of the ASR. Furthermore, because the US does not have a national registry system, this figure likely represents significantly less than the total number of problems experienced by ASR hip replacement patients.

Other Concerns with Hip Replacement

The current recall for the DePuy is almost silent on another, related problem with the ASR hip replacement system. Some of the unit failures are due to a problem that may be endemic to all metal-on-metal prosthetic joint replacements, such as the ASR. In these joint replacements, the metal pieces grind together, releasing numerous tiny metal fragments. These fragments irritate and damage nearby tissues and enter the bloodstream. The full effects of these fragments are not known. At this point, they have been shown to cause ongoing pain and loss of bone and soft tissue adjacent to the prosthetic device, which requires that the prosthetic be replaced in complex operations that can lead to long-term complications. One study showed that over half of surgeries to correct this issue must be followed up by at least a third hip surgery.

The metal fragments consist of many metals, including chromium and cobalt, which are known to be toxic. No one has yet established what constitutes a safe level of these metal fragments, and it is possible that ASR hip replacement recipients may suffer permanent damage including inflammation of the bowels and kidneys (which can be fatal), as well as heart, nerve, and thyroid problems.

We Can Help

If you have suffered an ASR hip replacement failure and/or the painful side effects of metal fragments from the ASR hip replacement, you may be eligible for compensation for your injuries. The product liability lawyers of Jacoby & Meyers stand ready to help. Please contact us today for a free initial consultation.