Responsibilities when confronting a defective surgical implant.
The senior author shares lessons from his experience with faulty knee implants that resulted in severe polyethylene wear and 51% failure of 73 unicondylar knee arthroplasties within 2 years after implantation. Ensuing research showed that the components had been sterilized by gamma irradiation in air and had shelf lives ranging from 4.5 years to 6.5 years. It was learned that gamma-irradiated components with more than 5-year shelf lives remain in inventories without information showing their sterilization dates. This experience reiterated the importance of staying abreast of the literature and reports concerning products and of being alert to unexpected patient outcomes relatively soon after implantation. If a surgeon suspects a faulty prosthetic device, he or she should contact the manufacturer and the United States Food and Drug Administration, so that an investigation can begin. In such situations, the physician's primary responsibility lies with the patient, and it is necessary to arrange extra time and staff resources to give the affected patients information, compassion, added clinical monitoring, and treatment. Because the potential exists for gamma-irradiated in air implants with lengthy shelf lives to remain undetected in inventories, the current authors recommend that surgeons select implants sterilized by a different process.
Engh
Gerard A
GA
Anderson Orthopaedic Research Institute, Alexandria, VA 22307, USA.
Wolf
Rebecca
R
D006801:Humans; D016365:Liability, Legal; D009985:Orthopedics / Q000331:legislation & jurisprudence*; D010819:Physician's Role; D011475:Prosthesis Failure; D012941:Social Responsibility; D014481:United States