Sulzer Press
Release June 18, 2001
Sulzer
Medica Updates Information to Annual Report
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WINTERTHUR,
Switzerland, June 18, 2001
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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.
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Inter-Op�
Hip Shell
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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.
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Tibial
Baseplate
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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.
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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.
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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.
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Financial
Impact
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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.
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Litigation
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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.
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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).
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THE SAFE
HARBOR STATEMENTS UNDER THE U.S. PRIVATE SECURITIES LITIGATION
REFORM ACT 1995
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This report
contains forward-looking statements including, but not limited to,
projections of future performance of materials and products,
financial conditions, results of operations and cash flows,
containing risks and uncertainties. These statements are subject
to change based on known risks detailed from time to time in the
Company's Securities and Exchange Commission filings and other
known and unknown risks and various other factors which could
cause the actual results or performance to differ materially from
the statements made herein.
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We handle
personal injuries claims from defective recalled hip and knee implants for clients
across the nation.
If
you want to preserve a potential legal claim for a defective hip or knee implant
products you believe you received, you should contact an attorney
immediately, since all states have mandatory time periods in which
lawsuits must be filed; otherwise, your case may be forever barred.
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Us Now
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