Inside the Sulzer Hip Recall

Inside the Sulzer Hip Recall

Southern California Senior Living, May 2001

Sulzer Orthopedics, an Austin, Texas corporation and one of the nation's leading manufacturers of artificial hips, describes total hip replacement as "a routine surgery with very predictable results. Over 300,000 Americans receive hip implants each year."

For Californian Cherie Lewis, her hip replacement was anything but predictable. While following her surgery last October she was progressing well, on the Sunday before Thanksgiving, Cherie Lewis woke up in pain that she described as "a 12 on a scale of 1 to 10." What Ms. Lewis and her doctors did not know at the time was that the implant she received was defectively manufactured. The faulty implant "literally took my life away," explained Ms. Lewis. "I had been given a 6- to 8-week time frame for recovery. And now I have to have a second surgery. I have something in my body that has actually pulled away from the pelvis."

Unfortunately, Cherie Lewis' experience is not a unique case. On December 8, 2000, Sulzer Orthopedics announced the recall of 17,500 of its Inter-Op™ shells used for hip replacement surgery. The Sulzer Inter-Op™ hip implant consists of a metal ball on a stem that is inserted into the thigh bone. The ball fits into a shell that is connected to the pelvis. Apparently, oil used to lubricate the machines that produced the hip shells seeped into coolant that was sprayed on the shells. The oil has been found to cause the shell to fail to bond with the body, resulting in the hip implant becoming loose.

Presently, it is not recommended that every person who received a recalled hip shell have it replaced. Only those persons who received the recalled hip shell and have symptoms of a defective hip implant, which include significant startup pain with ambulation (walking) or rising from a seated position, in consultation with their orthopedic surgeon, should consider corrective surgery.

However, to date, over 800 Sulzer patients have undergone revision surgery to replace the defective hip shell, with many more patients set to have revision surgery in the coming months. One orthopedic surgeon in Oakland, California has reported that half of his 225 patients will need corrective surgery. Hundreds of Sulzer patients throughout Southern California have contacted their doctors to learn if they have the recalled hip shells.

In its announcement of the recall, Sulzer apologized to patients for its manufacturing defect. In recent Court filings, however, Sulzer has denied any legal responsibility and blamed unidentified third parties for the recall. California law provides allows recipients of the recalled shells to assert several claims against Sulzer, including negligence and strict liability for producing a defective product used in the body. Damages under these claims include past and future pain and suffering, as well as recovery for lost wages and medical expenses. It has been alleged that Sulzer was aware of multiple cases of loosening of its hip implants months before it announced the recall. Such allegations, if proved, could expose Sulzer to punitive damages.

Stephen H. Cassidy is an attorney with Lieff Cabraser. To learn more about the Sulzer hip replacement recall, click here.