



ASR Hip Replacement Recalled By DePuy Orthopedics, Inc.
Patients who received hip replacements should check immediately to see if their hip replacement system is the DePuy ASR XL Acetabular System™ or the DePuy ASR Hip Resurfacing System™. Johnson & Johnson, and its DePuy Orthopaedics subsidiary, have recalled these hip replacement systems according to an August 2010 announcement.
A recent study revealed one in eight patients will be forced to undergo revision surgery due to defects in the ASR system. That report stems from data compiled by the National Joint Registry (NJR) of England and Wales, which revealed the ASR devices have a revision rate of approximately 12% - 13%. While these rates are across all device sizes, device head sizes smaller than 50 mm in diameter and those implanted in females have the highest rate of failure.
The defect is due to the device’s metal-on-metal design, which sheds metal debris into the patient’s body. As a result, some patients experience bone loss, inflammatory reactions and soft tissue damage. Additional problems reported by patients include pain, swelling and difficulty walking. Other health issues caused by the devices include misalignment, loosening of parts, and broken bones.
Globally, 93,000 patients have received hip replacement with the ASR XL Acetabular System or the DePuy ASR Hip Resurfacing System.
Medical professionals have issued increasing warnings about metal-on-metal hip implants. DePuy announced in 2009 that the design would be discontinued in an effort to focus on more modern, emerging technologies.
DePuy officials issued a press release in August, 2010, announcing the recall.The U.S. Food and Drug Administration (FDA) and other global regulatory agencies have been notified.
Within that press release, DePuy Orthopedics president David Floyd stated, “We regret that this recall will be concerning for patients, their family members and surgeons,” said. “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.”
DePuy has agreed to cover “reasonable and customary costs” related to monitoring, treatment, and revision surgeries. Because of this, and because lawsuits have already been filed in San Francisco, Los Angeles and New Jersey, product liability attorneys are recommending that patients who have received one of these hip replacement devices seek immediate assistance. Lawsuits allege DePuy knew of the design defects and took no action.
U.S. and Canadian patients and health care professionals can get more information at www.DePuy.com, or can call 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients outside the U.S. and Canada may call collect, +1 813-287-1651 24, hours a day, seven days a week.