Sulzer Orthopedics Inc. is a designer, manufacturer and distributor of orthopedic implants for hips, knees, shoulders, and elbows. One of its products is known as the “Inter-Op acetabular shell,” which is one component of a system used for complete hip replacements. Specifically, the Inter-Op shell is a socket-like device inserted into the acetabulum, which is a part of the pelvis; the shell is designed to receive a separate, ball-like device, which is inserted into the femur, or thigh bone. The Inter-Op acetabular shell was designed to bond with the natural bone.
Unfortunately, a manufacturing defect apparently prevented some of Sulzer Orthopedics’ Inter-Op shells from bonding with the acetabulum. In early December of 2000, Sulzer Orthopedics announced a voluntary recall of certain manufacturing lots of its Inter-Op shells. Most of the recalled products were manufactured during or after October of 1999, but a limited number were produced as early as June of 1997. The recall stated that Sulzer Orthopedics had “received reports of post-operative loosening” of some of the Inter-Op shells, apparently “related to a reaction of the body to a slight residue of lubricant used in the manufacturing process.”
Sulzer Orthopedics recalled approximately 40,000 units of its Inter-Op shell, of which about 26,000 had already been implanted in patients. About 90 percent of these implants occurred in the United States. About 2,400 of the patients who received implants of the Inter-Op shells have undergone revision surgery — removal of the defective implant and replacement with a new one. For a variety of reasons, not all of the patients who were implanted with recalled Inter-Op shells will undergo revision surgery. The defect has been alleged, but not necessarily proven. If you have been injured by a Sulzer product, contact an attorney.