In 2000, Sulzer Orthopedics noticed higher than normal revision surgeries on their InterOpAcetabular Shell. The shell was held to the pelvis with screws, yet these sockets started to loosen. Patients experienced persistent and sharp groin pain due to this loosening and were unable to bear their weight on the leg that had the implant. Approximately 25,000 shells were affected. 17,500 of these were already implanted in patients. Following weeks of investigation of patients record, surgical techniques, and the product itself, the company ordered a recall. Sulzer eventually agreed to $1 billion settlement with affected patients.
Category: Implant Retrieval and Evaluation
The Prozyr Femoral Ball Recall
In 2001, in European and American regulatory agencies recalled millions 
of zirconia ball heads sold under the commercial name Prozyr by Saint Gobain Ceramiques Desmarquest. These heads are one of the important components used in a total hip replacement procedures also known as arthroplasty. This recall happened because the femoral ball heads were fracturing and failing at inordinately high rate after implantation in patients in a relatively short period of time. What followed was an intense international investigation by a panel of experts. The company and regulatory agencies wanted to find out answers to two central questions as soon as possible. What caused these fractures that led to the failure of these implants? What changed that caused this sudden jump in failure rates?