Stryker Orthopedics has issued a recall of its Rejuvenate and ABG II modular-neck stem hip replacement systems. This hip system has been in use since approximately 2009 and was reportedly promoted by Stryker’s sales representatives as enabling surgeons to better customize the implant for any given patient, and as having a better and longer-lasting fit. However, in April 2012, Stryker Orthopedics issued an “Urgent Field Safety Notice” acknowledging a potential link between the Rejuvenate Modular Hip Implant System and a condition known as “metallosis”. Reported complications from metallosis include bone damage, significant pain, tissue damage, abnormalities in blood chemistries, and allergic reactions. The US FDA has reportedly received over 60 adverse event reports for these hip systems to date, and Health Canada has reportedly also taken its own action to recall the device system.
Patients with this implanted hip replacement system who are experiencing complaints of pain, swelling, immobility, premature loosening, or other complications may potentially require revision surgery, and are urged to contact their orthopaedic surgeons for further assessment.