Hip Replacement Recall (Hip Implant Failure)

There has been much talk recently regarding hip implant failures and recalls of hip implants. Hip replacement failures include the loosening of the components, the mal-alignment of the components, infections, bone fractures, dislocations,  sensitivities to the metals used in the components (including soft tissue reactions to metal debris due to wear), and pain. Whereas the anticipated length of time that a hip replacement is expected to last is approximately 15 years, pre-mature failures result in the need for additional surgery and unnecessary pain and suffering.

In August, 2010, DePuy Orthopaedics Inc., a Johnson & Johnson Company, issued a voluntary recall of its DePuy ASR products due to higher-than-expected revision rate at five years. A “revision” is when a hip implant is surgically removed and replaced with a new hip implant. The DePuy ASR systems first became available in July, 2003. The DePuy ASR Hip Resurfacing System was only approved for use outside of the United States but the ASR XL Acetabular System was available throughout the world, including the United States. The five-year revision rate for the DePuy ASR devices was approximately 12% to 13%. Source

The ASR XL total hip replacement involved a one-piece metal component known as an acetabular cup that was placed in the acetabulum (the concave surface on the pelvis in which the femoral head normally sits). The femoral head was replaced with a metal ball which was connected to a metal stem placed inside the femur (the thigh bone).

The DePuy ASR Hip Resurfacing System involved an acetabular cup placed in the acetabulum and a metal cap placed over the femoral head.

Source

The recalls have became known as and referred to as the DePuy Hip Replacement Recall, the DePuy Hip Implant Recall, or the DePuy Hip Recall in the news media and elsewhere. DePuy has agreed to reimburse patients for certain medical costs, lost wages, and travel expenses related to the recall. Some attorneys are also handling litigation regarding the recall and the effects that the recall have had on patients directly affected by the recall.

On June 13, 2011, the U.S. Food and Drug Administration (FDA) approved the first ceramic-on-metal total artificial hip replacement for patients suffering from osteoarthritis. The Pinnacle CoMplete Acetabular Hip System, which is manufactured by DePuy, is the first to combine a ceramic ball and a metal socket (previous hip replacement systems used combinations of metal, ceramic, and a form of plastic known as polyethylene). The Pinnacle was subjected to a two-year clinical study of 194 patients who received the Pinnacle ceramic-on-metal hip implant and 196 patients in a control group who received a metal-on-metal hip implant.  Two of the patients who had received the Pinnacale needed to have the implant replaced compared to three patients who needed to have their implants replaced who had received the metal-on-metal hip implant. The FDA’s approval requires that DePuy monitor patients who receive the Pinnacle for adverse events and metal ion concentrations in their blood (wear in the implant results in very minimal metal debris).

Source

If you or a family member received a hip implant that is subject to a recall, or has failed prematurely, you may be entitled to compensation for your losses and injuries. Visit our website to be connected with medical malpractice lawyers who may be able to assist you with your claim. We may also be reached toll free at 800-295-3959. Turn to us when you don’t know where to turn.

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This entry was posted on Thursday, August 25th, 2011 at 10:51 am. Both comments and pings are currently closed.

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