A recent warning to doctors from DePuy Orthopaedics, a division of Johnson & Johnson, suggests that the DePuy ASR metal-on-metal hip replacement system may be associated with a higher-than-normal failure rate in certain patients, including women, people of small stature, and those with weak bones.
Last fall, the company announced that the device will be phased out of the market by the end of 2010, citing sluggish sales with no mention of the high failure rate. The DePuy ASR (Articular Surface Replacement) system has already been removed from the Australian market in December 2009 after an Australian report revealed very high failure rates for the devices.
Since early 2008, the U.S. Food and Drug Administration has received nearly 300 complaints of the ASR hip implants causing problems, many of which require the patient to undergo costly and painful additional surgeries to have the defective implant replaced.
Many reports describe loose cups, allergic reactions to metallic debris, or the development of a pseudotumor, or a soft tissue mass that forms as a result of toxic reactions to an excess of metal debris. Severe reactions can lead to permanent muscle and tissue damage and prevent the cup from bonding to bone as it is designed to do.
Some doctors feel that the ASR cup design itself is flawed, as it is shallower than other systems and more difficult to implant properly when compared to competitors’ cups.
Dr. Stephen Graves, director of an implant database in Australia, says that the data has shown for some time that the DePuy ASR has been failing early at a significantly higher rate than competitors’ devices. A U.K. study last year showed that, out of 660 patients studied, 3.4 percent of patients who received metal hip implants from DePuy Orthopaedics suffered from adverse reactions to metal debris.
The DePuy ASR metal-on-metal hip replacement device has been implanted in more than 13,000 patients worldwide since its approval. Patients who have had a hip replacement surgery since 2003 and are experiencing pain or discomfort should contact their orthopedic surgeon or the hospital where the surgery was performed to determine if the DePuy ASR hip implant was used.