The financial impact of Sulzer Orthopedics' Inter-Op acetabular shell hip implant recall Dec. 5 "will be more than offset" by a $32 mil. one-time payment from a separate litigation settlement to its Sulzer Spine-Tech subsidiary, the firm predicts.

However, Sulzer "continues to assess the impact" of the recall, and an expected "slow-down" in U.S. sales of the device early this year, on its financial results for 2001, the company says in a Jan. 18 release. The voluntary recall, which was announced Dec. 8 and affects roughly 17,500 patients who were implanted with the device, stemmed from a manufacturing defect that caused post-operative loosening of some of the shells (¹ Also see "Sulzer Orthopedics Inter-Op" - Medtech Insight, 11 December, 2000.). Related to a residue of lubricant on the exterior porous surface, the problem has been resolved by revising cleaning processes.

Sulzer notes that while 129 cases of aseptic loosening within the first six months after implantation have been reported to date, "due to the random nature of the problem, it is difficult to estimate the exact number of patients who may experience loosening of the shells." The Swiss company has pledged to reimburse for out-of-pocket expenses not covered by Medicare or insurance to replace or otherwise treat the defective implant. However, "Sulzer Orthopedics' surgeon advisers do not recommend that patients undergo removal of the Inter-Op unless they exhibit symptoms of loosening."

"We deeply regret this incident. We accept full responsibility for the recall," commented CEO Andre Buchel. A toll free number has been established to address patient concerns at 800-888-4676, ext. 232.

While the Inter-Op has been on the market since 1996, the affected devices were sold primarily in the U.S. after October 1999; a small number of lots sold after July 1997 also are affected. The recall stemmed from reports received since mid-September 2000. Following an investigation, Sulzer determined that the residue remained on the shells' surface following the machining process at its plant in Austin, Texas. The residue may prevent the implant from correctly bonding with the bone, resulting in loosening. Symptoms include pain and the inability to bear weight on the affected limb. No other Sulzer products were affected by the defect, the firm says.

Sulzer Inter-Op Hip Shell Loosening Detected In 129 Patients Following Recall

More from Archive

More from Medtech Insight