In August 2010, DePuy Orthopaedics, a unit of Johnson & Johnson, issued a voluntary recall of its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System after receiving new, then-unpublished data from the National Joint Registry (NJR) of England and Wales as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System. [U.S. Department of Health and Human Services, U.S. Food and Drug Administration, (January 17, 2013). Metal Devices. Retrieved from this article published by the FDA.
This data showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System, which was not in line with data previously reported to DePuy. These revision rates were across the entire size range.
DePuy’s previous analyses of collective post-market data from a variety of sources had shown lower revision rates.
The DePuy Orthopaedics ASR Hip System first became available in July 2003, but it first became commercially available in the U.S. in December 2005. The artificial hip socket was sold to some 35,000 people in the U.S. and more than 90,000 people worldwide. New Brunswick, N.J.-based Johnson & Johnson stopped making the product in 2009.
DePuy and Johnson & Johnson have not accepted responsibility for the alleged defects and failure of their artificial hip implants. As a result, hip replacement patients who received DePuy metal hip implants continue to file lawsuits against DePuy for their injuries.
During a recent court case, Johnson & Johnson indicated that officials of the company were aware of problems with the device at least as far back as 2008. Johnson & Johnson has put aside around $1 billion to deal with the costs of the recall and lawsuits. [Associated Press, (January 28, 2013). Trial over metal hip replacements begins in LA. Retrieved from https://www.cbsnews.com/news/trial-over-metal-hip-replacements-begins-in-la/
Since the DePuy ASR hip recall, the entire class of metal-on-metal hip implants have come under close scrutiny. The U.S. Food & Drug Administration (FDA) issued their first public safety communication about metal-on-metal hip devices in February 2011. This is despite the fact that in November 2010 DePuy published the first ASR Recall Resource Packet in November 2010. On May 6, 2011, the FDA issued a post-market surveillance study of total metal-on-metal hip replacement devices. Most recently, on January 17, 2013, the FDA proposed an order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval applications. This would make the devices ineligible for 501(K) clearance, which allowed such implants to come to market with no human testing. The proposed rule would require manufacturers to submit data showing the devices are safe and effective before they could continue selling existing ones or obtain approval for new mental-on-metal designs. [DePuy Companies (2011). DePuy ASR Recall Guide.
All artificial hip implant devices can have complications. In metal-on-metal devices both the ball and socket components are made of metal. Because of the metal’s durability, metal-on-metal devices were expected to last longer than other hip implants. They were also widely used because they avoid the complication of debris wear from implants made of plastic. However, as in the case of the ASR Hip System, metal surfaces give off small particles of debris. Metal surfaces can corrode, giving off metal ions. Despite all precautions by orthopedic surgeons before and during hip replacement to try to optimize the way in which the ball and socket rub against each other so that fewer particles are produced, these ions (e.g. cobalt and chromium) and particles can enter the space around the implant, as well as enter the bloodstream. Over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery.
There have been some case reports and articles in the medical literature that suggest patients with metal-on-metal hip implant may have certain symptoms or illnesses else in the body (systemic reactions), likely caused by high metal content in the bloodstream. These include: general hypersensitivity reaction (skin rash), cardiomyopathy, neurological changes including sensory changes, psychological status change (including depression or cognitive impairment), renal function impairment, and thyroid dysfunction.
At the current time, the FDA is recommending that asymptomatic patients with metal-on-metal implants continue to follow-up with their orthopedic surgeon every 1 to 2 years to monitor for early signs of change in hip status.
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