This article is part of the Arthritis Archives.
Dateline: May 24, 2001
More Problems For Sulzer
On May 21, 2001, Sulzer Orthopedics, Inc. declared in a press release that there have been 1,700 revision surgeries performed as a result of the voluntary recall of the Inter-Op hip implant. The recall was announced on December 5, 2000, at which time Sulzer expressed a commitment to the fair reimbursement of medical expenses, lost wages, and the pain and suffering of affected patients.
On a weekly basis, the number of revision surgeries is declining. Sulzer believes that most problems with the Inter-Op hip implant occur within the first six months. The expectation is that the most critical period has passed, though Sulzer is not offering a prediction the final number of revision surgeries which ultimately will result from the recall.
Investigating Hip Failure Cause
Sulzer has continued to investigate the cause of the hip failure. It was originally suggested that a trace of mineral oil-based lubricant remained on the implant after the manufacturing process, causing a problem with bonding between the implant and bone. Along with the residue as the likely cause for the problem, Sulzer is looking at elements within the mineral oil-based lubricant. While the investigation continues, Sulzer has implemented steps in the manufacturing process to prevent recurrence of the problem.
Porous-Coated Tibial Baseplates
Sulzer has informed the Food and Drug Administration (FDA) that there may also be problems with a porous-coated tibial baseplate, manufactured from July to December 2000. There have been a few reports of problems in the clinical setting. Investigations are inconclusive but Sulzer is notifying the small number of surgeons who implanted the product. The porous-coated tibial baseplates by Sulzer are no longer on the market. Overall, 1,485 patients received the implant:
- 1,336 in the United States
- 97 in Europe
- 52 in Australia
Sulzer claims all other porous-coated products which they manufacture use a different production process and are unaffected.
In the press release, Sulzer also states that it can "no longer maintain its formerly expressed opinion that it is sufficiently insured." The number of revision surgeries involving the Inter-Op hip is already considerably higher than what was expected.
Related Resources
Source: Press Release - Sulzer Orthopedics Inc Updates on Inter-Op Recall and Scientific Investigation, Sulzer 5/21/01
First published: 5/24/2001
