Medical devices: Information on hip implants
Hip joint endoprostheses are medical devices of the highest risk class (class 3). These medical devices must undergo a development program with clinical studies. If the benefit-risk profile is appropriate, the device is certified by a notified body and may be used as a result. This benefit-risk profile is continuously evaluated within the framework of medical device vigilance. In Austria, the Federal Office for Safety in Health Care (BASG) is responsible for medical device vigilance.
The company DePuy recalled an ASR™ XL acetabular system and hip resurfacing system in August 2010. Reasons for the recall included an increased complication rate (implant-related revision rates due to component loosening, component misalignment, infection, bone fracture, dislocation, metal hypersensitivity, and pain) and metal wear of this "metal-on-metal" implant system. Generally, a revision rate (subsequent removal of the implants) of six to eight percent within five years is assumed for such implants. For the product in question, the rate is twelve to 15 percent. The Federal Office organized the recall in Austria in cooperation with the manufacturer and published an official safety warning for Austria on its website as early as September 8, 2010.
The implants were distributed in Austria from 2006 until May 2010. The manufacturer informed the treating physicians about the possible problems with the prostheses with the involvement of the BASG. All Austrian hospitals are required by the Medical Devices Operator Ordinance to maintain a mandatory implant registry based on the Medical Devices Act, which ultimately allows affected patients to be subsequently identified. According to the manufacturer, around 280 implantations were performed in Austria. Most of these were in Vorarlberg and Styria. The vigilance process, including recall, has proceeded properly in accordance with legal requirements.
Further inquiries:
Institute MonitoringDipl.-Ing. Dr. Ronald BauerE-mail: ronald.bauer @ages .at
