Massachusetts Attorney Office

Sulzer Hip Implant Recall FAQ's

Sulzer Orthopedics is a subsidiary of Sulzer Medical, an international implant manufacturing company based in Switzerland (it is traded on the New York Stock Exchange, symbol SM).  The company issued a voluntary recall in December 2000 involving certain lots of the Inter-Op acetabular shells for hip implants.  The implants were sold primarily in the United States after October 1999, with a small number of lots sold after July 1997.  During extensive testing of the Inter-Op manufacturing process, it was discovered that a portion of the acetabular components evidenced a residue of lubricant on the exterior porous surface of the shell.  It was determined that this residue may cause reactions in the hip area potentially leading to aseptic loosening of the shell.  The residue inhibits the shell from bonding with the bone, causing the shells to loosen and fail.

Approximately 17,500 products from the affected lots have been implanted, approximately 90% of them in the United States.  Sulzer has voluntarily recalled the defective hip implants and has notified the implanting surgeons as well as the Food and Drug Administration of this problem.  Gary Sabins, President of Orthopedics, issued the following statement: “Sulzer Orthopedics deeply regrets any effect this may have on patients who have received a shell covered by this recall.”

Patients with defective hip implants experience severe pain in the groin, buttocks, or inner thigh.  Additionally, patients may feel pain with weight bearing or simply rising from a seated position.