Thursday, January 24, 2013

FDA Safety Communication: Metal-on-Metal Hip Implants


Date Issued: Jan. 17, 2013
Audience:
  • Orthopaedic surgeons
  • Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
  • Patients who are considering or have received a metal-on-metal hip implant
Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors
Device:
Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys. 
  • Traditional total hip replacement systems
  • Resurfacing hip systems
Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers.  This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting. 


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