Press Release (June
18, 2001)
WINTERTHUR, Switzerland, June 18, 2001
Today Sulzer Medica will file its 20-F (Annual Report) with the US Securities and Exchange Commission. The filing includes most recent information on Sulzer Orthopedics’ Inc. voluntary recall of the Inter-Op hip shell as well as on the scientific investigation on the tibial baseplate produced from July to December 2000. As part of the upcoming spin-off from Sulzer AG, Sulzer Medica will make the document also available on its corporate website.
Inter-Op™ Hip Shell
As of June 12, 2001 Sulzer Orthopedics Inc. has received reports of slightly more than 1,900 revision surgeries. The number of revision surgeries reported to Sulzer Orthopedics Inc. on a weekly basis is declining. Sulzer Orthopedics Inc. believes that most of the problems experienced by patients have occurred within the first six months after receiving their implants.However, Sulzer Orthopedics Inc. is not in a position to make a prediction on the final number of revision surgeries. Sulzer Orthopedics Inc. continues to thoroughly investigate from a scientific standpoint the exact reasons why some level of mineral oil based residue causes adverse clinical outcomes. Sulzer Orthopedics Inc. has implemented manufacturing and cleaning steps to ensure that this problem does not occur again. This product was designed and manufactured exclusively in the US.
Tibial Baseplate
Sulzer Orthopedics Inc. has informed the regulatory authorities of its ongoing investigation of a porous-coated tibial baseplate that was manufactured from July to December 2000. A number of adverse clinical outcomes and approximately 65 revision surgeries have been reported.Sulzer Orthopedics Inc. has advised all surgeons who have implanted these tibial baseplates of these reports of adverse clinical outcomes, and recommended that they monitor patients who received one of these tibial baseplates for any adverse clinical outcomes.
The affected porous-coated tibial baseplates, which are no longer on the market, were implanted in approximately 1,600 patients globally; that is approximately 1,350 patients in the U.S., approximately 200 patients in Europe, and approximately 50 in Australia. Sulzer Orthopedics Inc. is not able to estimate the total number of patients who may need to have revision surgery, but based on information reported to Sulzer Orthopedics Inc. by implanting physicians, the number could be substantial. The results of the investigation of all other porouscoated products of Sulzer Orthopedics Inc. indicate that they are not affected because they were produced in a different process and have achieved successful clinical outcomes.
One lawsuit has been filed in connection with the tibial baseplate. Sulzer Orthopedics Inc. has received notice of other patients who received tibial baseplates who also may file suit based on similar allegations.
Financial Impact
As a result of the increased number of revision surgeries regarding the Inter-Op acetabular shells and the adverse clinical outcomes for its tibial baseplates, Sulzer Orthopedics Inc. believes that it is likely that the amount of expenses it will incur in connection with claims made by patients needing revision surgery as a result of the Inter-Op implant recall and the adverse clinical outcomes of its tibial baseplates will exceed the limits of the existing insurance coverage. There can be no assurance that any such uninsured expenses will not have a material adverse effect on the consolidated results of operations, financial condition, or liquidity of the Company. In such event, a significant exceptional operating expense could negatively impact earnings. Sulzer Orthopedics Inc. is committed to a fair reimbursement of all medical expenses, lost wages and pain and suffering incurred by patients whose implant fails due to early loosening.
Litigation
The Company and its subsidiaries have been named as a defendant in approximately 800 lawsuits (including 51 that seek certification of a class) that have been filed as of June 1, 2001.
Sulzer Medica’s subsidiaries develop, manufacture and market implantable medical devices and biological products for cardiovascular and orthopedic markets worldwide. The product offering includes joint prostheses, spinal implants, dental implants, trauma surgery products, heart valves, and vascular grafts (Swiss Stock Exchange: SMEN; NYSE: SM).