DePuy ASR Metal-on-Metal Hip Replacement Recipient Ready to Give FDA an Earful

A Pennsylvania man who was fitted with two defective ASR hip replacement devices made by DePuy Orthopaedics is preparing to travel to Washington, D.C. next month. According to a report from the Allentown Morning Call, Steve Lorenz is among the witnesses set to testify before a U.S. Food & Drug Administration (FDA) panel that will review the safety of metal-on-metal hip implant devices. Lorenz wants the FDA to know how much misery his ASR hip implants have caused, and hopes to help convince the agency to subject metal-on-metal hip replacements to greater oversight.

“If I walk too much at work or if I’m on my feet for too long,” Lorenz told the Morning Call. “By the end of the day I feel as bad, if not worse, as when I needed my first hip replacement.”

DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System were named in a global recall in August 2010. The recall was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years. A total of 93,000 implants were sold worldwide, including 37,000 in the U.S.

According to the Morning Call, Lorenz was struggling to recover from his second hip replacement surgery when he received a letter from Johnson & Johnson, DePuy Orthopaedic’s parent company, informing him that recalling thousands of its ASR metal-on-metal hip implants.

“It was disturbing,” Lorenz said. “Oh my God, I felt like a Ford truck. I got my hips recalled!”

Lorenz was just 48 in 2008 when he received his first DePuy ASR hip replacement device in the left hip. Unfortunately, Lorenz never recovered properly from the first surgery, and was experiencing what he described as “a loosening of the joints, like I have play in there.” He also had swelling around his scar, and was in constant pain.

Lorenz was told by doctors that his problems were due to a right hip that was wearing out, and it would also need to be replaced. He was fitted with a DePuy ASR hip replacement device in that hip in February 2010. The second surgery left Lorenz in even more misery.

Then in October 2010, he received notification of the DePuy ASR hip implant recall. Not long after, Lorenz got a call from his doctor, who wanted to check the levels of cobalt and chromium in Lorenz’s blood. Though his levels were normal, Lorenz is still experiencing pain around his scars and has been forced to give up riding his bicycle, the Morning call said. He’s been struggling to find a doctor willing to perform a complicated revision surgery to replace his failing hip implants.

Like many metal-on-metal hip implants, the DePuy ASR hip replacement device was approved through the agency’s 510(k) clearance protocols, which does not require human clinical trials. Next month, when Lorenz testifies at a meeting of the FDA’s Orthopaedic and Rehabilitation Devices Panel, Lorenz plans to tell the agency that must change.

Metal-on-Metal Hip Implant Complication
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The FDA began studying all-metal hip implants shortly after the DePuy ASR hip implant recall. Last May, it directed 21 companies that market all-metal hip replacements, including DePuy, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. The FDA’s advisory panel is scheduled to take up metal-on-metal hip implants during a two-day meeting scheduled for June 27th and 28th.

Some have called for an end to the use of metal-on-metal implants, following several recent studies that pointed to their dangers. In March, a large study published in The Lancet showed that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years. A month earlier, a British Medical Journal/BBC investigation revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking the devices to serious, long-term health consequences, but for years failed to warn the public about these dangers. The report warned that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic and potentially cancer-causing metals from failing metal-on-metal hip implants.

DePuy ASR Hip Implant Lawsuits
Since the DePuy ASR hip implant recall, thousands of people have filed suit against Johnson & Johnson and DePuy Orthopaedics. More than 4,200 lawsuits are pending against the companies in a federal multidistrict litigation now underway in the U.S. District Court for the District of Northern Ohio. Bellwether trials in that litigation are expected to start early next year.

Another 2,000 lawsuits are also pending in state courts. Two DePuy ASR hip implant trials are set to start in Nevada and Maryland later this year.

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