On December 8, 2000, Sulzer Medica published a press release announcing that its Texas based subsidiary, Sulzer Orthopedics, was voluntarily recalling 24,000 of its “Inter-Op acetabular shells,” or hip implants. The recall stemmed from a production error in which the Inter-Op shells had retained a slight oil residue that was supposed to be completely removed prior to surgery. When the oily residue was not removed, it could cause the shells to loosen or fail.
The Inter-Op shells were implanted in patients beginning in August 1997 until the December 8, 2000 recall. In October 1999, Sulzer Orthopedics began to suspect problems with their manufactured hip implants that were fitted with the Inter-Op shells. Although such problems were being reported early on, most of the recalled Sulzer hip replacements were implanted after October 1999.
Soon after the December 2000 recall, Sulzer reported that only
61 cases of loosening of the shell had occurred since October
1999. However, the number of reported injuries increased rapidly
over the next few months. In February 2001, Sulzer divulged 129
patients who had to have additional surgery to correct the defective
hip implants. In March 2001, Sulzer disclosed that as many as 573
patients had an implanted Sulzer hip shell that needed to be
replaced.
Patients with the recalled Sulzer hip implant complain of severe
pain in the hip, thigh, groin or buttocks, difficulty with walking, rising
from a seated position or general mobility. Some patients don’t
experience problems until years after the hip surgery.
