Stryker Rejuvenate, ABG II Modular Neck Stems May Fret, CorrodeJul 10, 2012 | Parker Waichman LLP
Stryker Corp. has issued a recall on metal hip implant components because they are prone to rust (or “fret”), a condition that’s likely to cause severe pain and inflammation at the site of the implant.
According to a report at MassDevice.com, the recall action focuses on the Rejuvenate Modular and ABG II modular-neck hip stems. The company said these components’ risk of fretting or corroding can lead to device failure and eventual replacement surgery. The company has ceased marketing and production of these devices.
The recall comes amid a whirlwind of skepticism regarding the overall safety of metal-on-metal hip implants. Tens of thousands of recipients of any myriad all-metal hips have suffered from any number of complications or defects tied almost exclusively to this class of device. All-metal hip implants were originally touted as the improvement upon previous implant technology. Their metal components were supposed to last longer and require less revision surgeries and less replacements during a lifetime. They were designed with younger recipients in mind but have proven to cause more harm than good in less than a decade on the market.
The discovery of the Rejuvenate Modular and ABG II modular-neck hip stems’ greater risk of corrosion or fretting came during post-market safety testing being conducted by the company, as ordered by the Food and Drug Administration after it received thousands of adverse event reports involving all-metal hip implants. The FDA had allowed many of these devices onto the open market without requiring much pre-market safety testing [via its 510(k) “fast track” approval system], believing they were similar in design to previously-approved hip implants.
Alarms over the entire range of metal-on-metal hip implants rang loudest when DePuy Orthopaedics recalled its failed ASR line of products in September 2010. In the nearly two years since, the FDA has ordered 33 makers of these implants to conduct thorough post-market surveillance of their products while it conducts inquiries on how best to deal with patients who are currently relying on a potentially defective hip implant.
The Rejuvenate Modular and ABG II modular-neck hip stems included in the Stryker recall were designed to “facilitate femoral component insertion in more technically challenging surgical approaches,” the report cites of a Stryker prepared statement on the recall. The company said it acted to recall the devices after discovering its higher risk of corrosion and believed it could be a “trend.”
Stryker also said, “It has been shown that a similar reaction and potentially premature failure of the total hip arthroplasty may occur in rare cases of patients with both modular head and modular-neck femoral components.” The statement added that pain at the site of the femoral neck should be addressed quickly by a surgeon to avoid future complications.