The Therapeutic Goods Administration (TGA), Australia issued a medical device safety alert concerning ABGII Modular Femoral Stem and Modular Neck manufactured by Stryker Australia Pty Ltd.
According to the manufacturer, there is potential for fretting and corrosion at the join between the femoral stem and the neck component of the ABGII Modular System. Fretting and corrosion can result in metal debris in and around the hip joint. If this occurs, patients may experience inflammation, adverse local tissue reactions (ALTRs), hypersensitivity/allergic reactions and osteolysis (bone loss).
Stryker Australia Pty Ltd has contacted every Australian orthopaedic surgeon who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. If the results reveal that adverse local tissue reaction of patients are due to metal wear debris, the surgeon should consider proceeding with a revision of the femoral component to a monolithic stem.
The manufacturer also advised patients that if experiencing hip or thigh pain, or are concerned about the hip replacement, they should contact their implanting surgeon to arrange a review appointment.
For details, please refer to TGA website
http://www.tga.gov.au/safety/alerts-device-abgii-120720.htm.
Posted on 23 July 2012