Recent information further implicates DePuy Orthopaedics for the problems associated with its ASR artificial hip replacement system. On September 27, 2011, the Australian Senate Community Affairs Committee conducted an inquiry into that country’s regulatory standards for medical devices. During the Senate hearing, witnesses testified that in 2006 DePuy had evidence of failure rates greater than 50% associated with the ASR hip. That information was not acted upon for over three years. Australia became the first country to issue a DePuy ASR hip recall in December 2009. The DePuy ASR hip was not recalled in the United States until August 2010.
Failure of the metal on metal ASR hip device can occur in a variety of ways, including fractures, dislocations, and soft tissue damage. Metal debris inside the body can cause inflammatory reactions, bone loss, genetic damage, aseptic fibrosis, local necrosis or other problems. failures often require revision surgery to remove the defective hip, but tissue and bone damage caused by metal debris greatly complicates subsequent procedures. Even with successful revision surgery, patients are often left with a substantial functional impairment due to bone and tissue damage. The long term effects of systemic cobalt and chromium poisoning are still being evaluated.
It is unclear how many DePuy ASR hip systems were implanted in patients in the United States prior to the August 2010 recall, or how many of those have required revisions. This is because unlike Australia, New Zealand and Sweden, the United States does not have a mandatory national registry for artificial joints. Instead the United States has a voluntary complaint reporting system (adverse event reports) administered by the Food and Drug Administration (FDA). A review of Adverse Event Reports revealed that nearly 4,000 of the 5,000 complaints received by FDA between January and June 2011 for metal-on-metal hips involved DePuy.
The FDA has been criticized for failing to have a mandatory national registry like Australia. In response, the FDA has requested the authority to require device manufacturers to perform post approval testing when problems develop after a device has been approved and entered the U.S. marketplace. Both of these measures are desperately needed, and may soon happen.
In December, 2011 a bipartisan Patient Safety Bill was filed in Congress that would for the first time require medical device manufacturers such as DePuy Orthopaedics to maintain a national registry to track implanted medical devices, creating a complete, accurate database of long-term safety, performance and failure. The Bill would also grant the FDA the authority to order companies conduct safety studies on devises after they have been approved. If passed, these measures will help protect future patients from poorly designed and inadequately tested medical devices. Unfortunately, the only protection available to victims of a defective DePuy ASR replacement hip is financial compensation from the litigation. SUGARMAN is committed to helping patients who have been harmed by a DePuy ASR artificial hip.
If you have any questions regarding a DePuy hip, please complete a Contact Form or call Stephen Sugarman or Benjamin Zimmermann at 617-542-1000 or email or .