Washington, DC: Stryker Orthopaedics has voluntarily recalled its Rejuvenate Modular and ABG II modular-neck hip stems. The voluntary recall was initiated due to the potential risks associated with modular-neck stems, including the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.
The Stryker Rejuvenate is not a metal-on-metal hip device, but it does have metal-on-metal components, which are believed to be responsible for the development of metallosis in some patients. According to reports, the Stryker Rejuvenate hip implant device is linked to a high early failure rate, resulting in some patients having revision surgery to replace their hip replacement device.
This latest hip implant recall puts focus on the FDA 510(k) medical device approval process which, in effect, excuses medical device manufacturers from the need for clinical trials and thorough pre-market testing in order to gain approval. The 510(k) procedure was initially created in order to streamline the FDA approval process for new medical devices; if the manufacturer could show that a new device was “substantially equivalent” to a device already on the market, it could potentially bypass the standard and more rigorous FDA approval process and be "fast-tracked" to the marketplace.
The Stryker Rejuvenate hip implant was approved via the FDA 510(k) "fast track" approval process in 2008--and the device that it was considered to be "substantially equivalent" in design to was the Wright Medical Technology Pro-Femur Total Hip Modular Neck System--and that hip implant has also associated with patient injuries.
On May 28, 2012, Health Canada announced that Stryker Rejuvenate was being recalled so the instructions for use could be updated. The recall affected only Rejuvenate devices sold in Canada and was based on a reported rate of less than one percent for revisions associated with the Rejuvenate. The recalled Canadian devices are:
A) Rejuvenate Modular Neck, 0 DEG
B) Rejuvenate Modular Neck, 8 DEG
C) Rejuvenate Modular Neck, 16 DEG
D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ