There have been at least 45 adverse event reports from patients who say the devices caused pain and/or tissue swelling.
Michigan-based Stryker, which has its biotech division in Hopkinton, Mass., said this week it would remove Rejuvenate and ABG II modular-neck stems, which attach to artificial hips, from the market and cease global distribution. The company said the incidence of complications is extremely low, but patients who experience symptoms of pain and/or swelling at the local joint site not attributable to other conditions, should speak to their surgeon.
“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” Stryker Vice President and General Manager of Hip Reconstruction Stuart Simpson said in a statement.
Simpson said the company would work with the medical community to better understand the problems with the devices as the company continues to evaluate the adverse event data. This includes at least 45 reports of injuries, using the Rejuvenate modular-neck stem, since the beginning of 2012, according to the FDA.
The company is encouraging patients who received a Rejuvenate Modular or ABG II modular-neck stem to contact their surgeon. A dedicated patient call center can be reached at 1-888-317-0200 and additional information can be found at www.AboutStryker.com/ModularNeckStems3