Misery of Two DePuy ASR Hip Implants Sending Pennsylvania Man to FDA HearingMay 11, 2012 | Parker Waichman LLP
A man from Pennsylvania who received two recalled DePuy ASR hip implants is preparing to tell his story to a panel of U.S. Food & Drug Administration (FDA) advisors in Washington D.C. next month. The panel is reviewing the safety of metal-on-metal hip replacement devices, and Steve Lorenz is hoping his story will help convince the agency to subject such devices to stricter oversight.
Currently, metal-on-metal hip implants, like the DePuy ASR hip replacement device, are approved through the FDA's 510(k), which doesn't require a medical device to undergo human clinical trials if the device is shown to be "substantially equivalent" to others already on the market. Many critics believe that problems with the recalled DePuy ASR hip implant and other defective medical devices would have been spotted prior to their approval if they were subjected to human testing. That may have saved Lorenz and others like him who received an ASR device a tremendous amount of misery.
Lorenz was just 48 in 2008 when he received his first DePuy ASR hip replacement device in his left hip. Unfortunately, Lorenz never received the relief he had hoped for, and instead experienced 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.
According to a report in the Allentown Morning Call, doctors told Lorenz that his problems were due to a worn out right hip, which 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.
In October 2010, Lorenz received notification of the DePuy ASR hip implant recall. Today, he continues to experience pain in both of his hips. Lorenz told the Morning Call that he hasn't yet been able to find a doctor willing to perform a complicated revision surgery to remove his failing implants.
"If I walk too much at work or if I'm on my feet for too long," Lorenz said. "By the end of the day I feel as bad, if not worse, as when I needed my first hip replacement."