Sulzer Medica to voluntarily recall Inter-Op hip shells: Press Release
Sulzer Medica announced today that its subsidiary, Sulzer Orthopedics has voluntarily recalled certain manufacturing lots of its Inter-Op acetabular shells for hip implants sold primarily in the United States after October 1999, with a small number of lots sold after July 1997. During recent exhaustive testing of its Inter-Op manufacturing process, a very low percentage of acetabular components evidenced a slight residue of a lubricant on the exterior porous surface of the shell. Our specialists and independent scientists consulting with Sulzer Orthopedics have concluded that this residue may cause reactions in vivo potentially leading to aseptic loosening of the shell.
Since mid-September 2000 Sulzer Orthopedics has received reports
of post-operative loosening of a number of the Inter-Op acetabular
shells. According to an extensive investigation, these random
cases appear to be related to a reaction of the body to a slight
residue of a lubricant used in the manufacturing process. Based
on a random sampling of affected product lots, a small number
of products evidenced a higher than expected level of this residue.
Approximately 17,500 products from the affected lots have been
implanted, approximately 90% of them in the US.
From October 1999 to date, 61 cases of loosening, or less than 0.5% of the total number of implanted shells have been reported.
Sulzer Orthopedics has notified the implanting surgeons, the Food and Drug Administration and other regulatory agencies and implemented changes to its manufacturing process to address the cause of the problem. There is no indication that any of the other products manufactured by Sulzer Orthopedics or any other subsidiary of Sulzer Medica are affected by this phenomenon.
The new bearing surfaces introduced by Sulzer Orthopedics in the US in recent months, Metasul and Durasul, are in no way related to the Inter-Op recall. The Inter-Op shell was introduced to the market in 1996 and except for this incidence, has demonstrated excellent clinical results.
Sulzer Medica does not expect a material financial effect as a result of the voluntary recall.
Gary Sabins, President of Sulzer Orthopedics, said: "Sulzer Orthopedics deeply regrets any effect this may have on patients who have received a shell covered by this recall. Only a very small number of patients who have received one of these shells may require medical intervention other than standard post-operative monitoring. Sulzer Orthopedics is not recommending prophylactic removal of the affected product. In the best interest of our patients and surgeons, we have chosen to err on the side of caution with this strictly voluntary action. Based on exhaustive testing, we have identified the problem and implemented and validated improvements in the manufacturing process to ensure production of the highest quality parts possible."
Headquartered in Winterthur, Switzerland, Sulzer Medica develops, manufactures and markets implantable medical devices and biological products for cardiovascular and orthopedic markets worldwide. The Company's product offering includes joint prostheses, spinal implants, dental implants, trauma surgery products, heart valves, and vascular grafts (Swiss Stock Exchange: SMEN; NYSE: SM).
The SAFE HABOR STATEMENT UNDER THE PRIVATE SECURITY LITIGATION REFORM ACT OF 1995: This press release contains forward-looking statements that involve risks and uncertainties, including, but not limited to projections of future financial condition, results of operations and cash flows. These statements are subject to change based on known and unknown risks and various other factors, which could cause the actual results or performance to differ materially from the statements made herein.
Winterthur, December 11, 2000
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