ASR XL Acetabular Total Hip Replacement
The ASR hip replacement systems produced by DePuy Orthopedics Inc., a subsidiary of Johnson & Johnson, are being voluntarily recalled due to design problems that result in unacceptably high failure rates. The worldwide recall announced in August of 2010 covers both the ASR XL Acetabular System and the ASR Hip Resurfacing System.
Only the ASR XL Acetabular System, which involves total hip replacement, was approved by the FDA for use in the United States. The ASR Hip Resurfacing System is not sold in the United States, but more than a few Americans have probably traveled overseas to take advantage of this more conservative, bone-sparing surgery. The combined total of hip replacement patients world-wide that are affected by the recall is close to 93,000.
The ASR XL Acetabular Total Hip Replacement system was first approved for sale in the United States in 2005, but several lawsuits filed since 2007 allege DePuy Orthopedics was aware of a high failure rate at the time of FDA approval. The suspected high failure rates were revealed when the results of a study conducted by the National Joint Registry of England and Wales was released in 2010. This study found a 13% five-year failure rate for the ASR XL Acetabular Total Hip Replacement system and a 12% five-year failure rate for the ASR Hip Resurfacing System. The failure rate is expected to be even higher for women who had an ASR XL Acetabular Total Hip Replacement using a ball diameter smaller than 50 mm. By comparison, a five-year joint replacement failure rate below 5% is generally considered acceptable. The expected number of patients needing to replace their ASR Hip Replacement/Resurfacing system over the next five years is close to 12,000.
The hip replacement side effects due to a defective ASR XL Acetabular Total Hip Replacement or ASR Hip Resurfacing system can include the following:
• Hip pain
• Hip swelling
• Problems walking
These symptoms may result from rapid wear of the joint, which in turn results in a loosening of the joint. If the joint becomes loose enough, it may dislocate during normal activities. Overtime, the bone around the implant may also acquire fractures. These are some of the more common, adverse hip replacement side effects.
Hip replacement side effects may also be caused by the unique, metal-on-metal design of the ASR replacement hip joint. This metal-on-metal surface interaction can reportedly cause problems by generating metal debris. This debris can then invade other parts of the joint and the surrounding tissues, causing an adverse reaction. A recent study found that up to 3.4% of ASR hip replacement patients may be suffering from adverse hip replacement side effects due to metal debris. The presence of metal debris in a patient’s body can be confirmed by a blood test.
Anyone who has had hip replacement surgery should talk with their doctor to determine whether they are eligible for this recall, and to discuss any adverse hip replacement side effects they may be experiencing currently. If you or a loved one are currently suffering from a defective ASR XL Acetabular Total Hip Replacement or Hip Resurfacing system, or have in the past, compensation through Johnson & Johnson may be available.
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