ASR Hip Replacement Recall
A hip replacement is a prosthetic device designed to help those whose mobility is hampered by disability or pain in their hip. By design, hip replacements are supposed to last for fifteen years or more. However, hip replacements often do not live up to the claims of their manufacturers. They may have early failures, causing significant pain, continuing disability, even systemic problems. One hip replacement with a record of higher-than-expected failure rates is the ASR, manufactured and marketed by DePuy Orthopaedics, a Johnson & Johnson company. Although it had resisted earlier calls, DePuy Orthopaedics initiated a voluntary recall of two ASR models on August 26, 2010, after data from several countries indicated they had a higher-than-expected failure rate.
This defective medical device has caused many people to have ongoing pain and subsequent revision surgeries, some of which were extensive and complicated operations, even leading to further operations and permanent pain or disability. If you or someone you love has suffered a premature failure of an ASR hip replacement, you may be eligible for compensation from the manufacturer. To learn about your legal options, please contact a local product liability lawyer for a free case evaluation.
About the ASR Hip Replacement Systems
The ASR is not one but three different related systems for providing partial or total replacement of the hip joint. To understand what makes the ASR special requires understanding the hip joint. The hip joint is made up of a socket in the pelvis, called the acetabulum, which fits around the ball of the femur, the long bone in your leg that runs from the hip to the knee. There are three different models of the ASR system, each replacing a different amount of the joint:
- The ASR Hip is a metal cup that replaces the acetabulum.
- The ASR Hip Resurfacing system is two metal cups, one that fits inside the acetabulum and one that fits over the ball of the femur.
- The ASR XL Acetabular System consists of three parts: an acetabular cup, a femoral ball, and a stem that fits inside the femur and attaches to the ball.
For the purposes of US citizens, the recall only affects the Hip and XL models of the ASR, since the Hip Resurfacing model was never approved for use by the FDA.
The Cause of the Hip Replacement Recall
Almost since its introduction, there have been concerns about the ASR hip replacement systems. In December 2009, DePuy responded to calls by Australian officials and removed the system from the market in that country after national registry data showed a high rate of failures. But it was not until a second national registry showed the system's alarming failure rates that the worldwide recall was put in effect. The National Joint Registry (NJR) of England and Wales suggested that the implants had a 12-13% failure rate within five years of implantation, about twice that of the Zimmer Durom Cup Hip Implant, which was recalled in 2008. Once this data was released, DePuy decided to initiate the recall, although not until after it had already decided to phase the implant out after sales of the unit had declined. However, the company is not yet admitting that these might be considered defective medical devices.
Other Concerns with Hip Replacement
The current recall by DePuy conceals another, related problem with the ASR hip replacement system. In some cases, the unit failure is due to a problem that may be common to all metal-on-metal prosthetic joint replacements, including the ASR. In this type of joint replacement, the metal parts grind together and shave off numerous tiny metal fragments. These fragments can irritate and damage nearby tissues and enter the bloodstream. It is unknown just what are the full effects of these fragments. They have been positively shown to cause ongoing pain and loss of adjacent bone and soft tissue. When nearby tissue is lost the prosthetic must be replaced in complex operations that can lead to long-term complications. In one study, it was shown that over half of surgeries to correct implant failure due to tissue damage must be followed up by at least a third hip surgery.
The fragments released consist of many metals, some known to be toxic, including chromium and cobalt. Doctors have not yet established what constitutes a safe level of these metal fragments. It is possible that ASR hip replacement recipients could suffer permanent damage including potentially fatal kidney and bowel inflammation, as well as heart, nerve, and thyroid problems.
Help Is Available
If you are suffering due to an ASR hip replacement failure and/or the painful and dangerous side effects of metal fragments from the ASR hip replacement, help is available. Our nationwide network of Injury Lawyers can help you fight for justice and receive compensation for your injuries. To learn more, contact a local lawyer today to get a free consultation.