Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include 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.
According to Stryker, patients with the recalled hip implant components should schedule an office visit with their surgeon if they are experiencing symptoms of a malfunctioning hip implant. Those without symptoms should continue to follow the post-operative plan their surgeon has outlined. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis.
This is the second time this year that a Stryker hip implant component has been implicated in a recall. In April, U.K. Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert on warning an increased rate of revision surgery among patients who had received DePuy Orthopaedic’s MITCH acetabular cup/modular head in combination with uncemented Stryker Accolade femoral stems. The warning was issued following an analysis of data from the England and Wales National Joint Registry, which discovered a cumulative revision rate of 8.8% for MITCH TRH hip resurfacing systems. When the DePuy MITCH hip was combined with the Accolade femoral stems, the failure rate increased to 10.7%.
MHRA indicated that patients who received the implant combination should be tested annually for signs of elevated cobalt and chromium blood levels from the hip replacement, which could indicate that they are suffering from metallosis.