Stryker Rejuvenate, ABG II Recall Could Boost Metal-on-Metal Hip Implant Lawsuit ClaimsJul 11, 2012 | Parker Waichman LLP
While Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems aren't metal-on-metal hip implants, it looks like the safety issues that prompted their recent recall could pose problems for the makers of all-metal hip implant devices. According to a report from Law360.com, the fact that the metal hip implant components recalled by Stryker have been linked to similar injuries undermines manufacturers' assertion that the safety of metal-on-metal hip implants should be evaluated on a device-by-device basis, rather than as a class.
Just last month, representatives from medical device makers made that very argument at a Food & Drug Administration (FDA) advisory panel meeting that was convened to examine the safety of metal-on-metal hip replacement devices. Johnson & Johnson and its DePuy Orthopaedics unit, Smith & Nephew PLC, Wright Medical Technology Inc, and Biomet Inc. are all expected to make similar arguments when they defend themselves against lawsuit involving metallosis and other injuries allegedly caused by the shedding of metal particles from metal-on-metal hips.
Stryker recalled the Rejuvenate and AGB modular-neck hip stems and terminated global distribution of the products after continued post-market surveillance indicated the devices may be prone to “fretting and/or corrosion at or about the modular-neck junction,” which may lead to pain, swelling and adverse reactions in surrounding tissue. Those problems are identical to the injuries suffered by victims of failing metal-on-metal hip implants, where the ball and socket of the device is made entirely of metal alloy. But the recalled Stryker components are two-part modular-neck systems that consist of a metal neck inside a metal stem. The fact that these hip replacement components are causing the same problems seen with all-metal devices could boost plaintiffs’ claims that any metal-on-metal junction can cause serious injuries.
"I think we're going to find more and more that these products are failing. When you put a metal-on-metal component in someone's body and subject it to the type of friction and stress these implants are, you're going to see problems with metallosis," one plaintiffs' attorney told Law360.com.