Stryker Recalls Two Metal Hip Implant Components Over Fretting, Corrosion IssuesJul 6, 2012 | Parker Waichman LLP
Stryker Orthopedics has quietly recalled two metal hip implant components over fears the devices could cause serious complications, including metallosis. According to a notice posted on Styrker's website, the company is voluntarily recalling its Rejuvenate Modular and ABG II modular-neck hip stems.
According to Stryker, use of modular necks was intended to allow greater technical precision when operating on artificial hip recipients. However, the company said it decided to voluntarily recall these Rejuvenate Modular and ABG II modular-neck hip stem systems because there is a potential for fretting and corrosion at the modular-neck junction which may lead to adverse local tissue reactions, such as metallosis.
Some patients fitted with either of the recalled Stryker modular hip stems may experience symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis. Patients with these systems should seek medical attention if they suffer from these symptoms.
The Stryker Rejuvenate Modular Hip System was cleared for sale in the U.S. via the U.S. Food & Drug Administration’s 510(k) process. This fast-track process allows a device to come to market without any human testing if a manufacturer can show it is substantially similar to a product already on the market. The predicate for the Rejuvenate hip system was the Wright Pro-Femur modular component, which has been named in numerous product liability lawsuits alleging it caused issues related to corrosion, fractures and adverse tissue reactions.