Sulzer Orthopedics Inc. ("Sulzer") began a voluntary recall of its Inter-Op Acetabular Shell on December 5, 2000 in response to reports that patients' pelvic bones failed to properly adhere to the implant within a realistic time after the operation. The failure of the implant has been directly linked to an unacceptable level of fugitive, mineral oil based lubricant found within the surface crevices of the porous Inter-Op Acetabular shell.
The lathes, used in the manufacture of the Inter-Op Acetabular shell, utilize mineral oil based lubricant on its sliding surface tracks called "ways". The lubricant was washed off of the exposed ways by the cutting fluid sprayed on the acetabular shell during machining. The way lube contaminated the cutting fluid and, when recycled, the contaminated cutting fluid caused the way lube to be sprayed onto the Acetabular shell and into its porous shell.
The oil contamination on the shell was not detected because no test was in place to test for it.
The evidence reviewed to date indicates that Sulzer does not know what level of oil contamination is acceptable for implantation in the human body. A hip implant that is released for use in the human body with an unacceptable amount of oil applied to it is unreasonably dangerous.
Sulzer admitted publicly that the presence of this lubricant residue could prevent the patient's hipbone from bonding with the affected hip implant. Sulzer then announced to surgeons, patients, and the public at large that when the lubricant residue prevented the patient's hipbone from bonding with the affected hip implant, the patient would experience such symptoms as severe groin pain and inability to bear weight on the affected leg.
Several thousand patients had acetabular shells implanted that had to be removed and replaced because the bone did not grow into the shell.
On Friday November 19 at 9:00 PM EST The Science channel is airing a television show on the Sulzer hip implant failure. http://www.thesciencechannel.com or http://tinyurl.com/6uwcm Dr. Jeffery Warren helps explain what went wrong in the hip manufacturing process, which led to hip failures in many patients.
For a complete look at this article with photos showing the hip failure analysis, please go to http://www.warren-group.com/sulzer/sulzer-sc.html