SULZER
ORTHOPEDICS INC. UPDATES ON INTER-OP RECALL
AND SCIENTIFIC INVESTIGATION
|
| WINTERTHUR,
Switzerland, May 21--Sulzer Orthopedics Inc. from Austin, TX, a
subsidiary of Sulzer Medica in Winterthur, Switzerland, announced
today that the number of revision surgeries performed as a result of
the Company's voluntary recall of its Inter-Op� hip implant
exceeds 1700 to date. This update reflects a recent consolidation of
several internal and external data bases registering information on
surgeries performed over the past five months. The number of
revision surgeries performed on a weekly basis is declining. The
Company continues to investigate intensively all potential causes of
the recall. |
| The
updated number of patients who had to undergo hip-revision surgery
is due to a recent and ongoing consolidation of patient data from a
variety of internal and external sources. Since surgeons are not
obliged to report revision surgeries to the Company immediately, and
hospitals tend to collect data on patients before they send it to
the Company, Sulzer Orthopedics had to establish a new data
collection system to register all patient information. This recent
consolidation has revealed a substantial number of formerly
unreported surgeries, leading to the current total exceeding 1700. |
| Gary
Sabins, President of Sulzer Orthopedics Inc., said: "We are
aware of the tremendous difficulties that some of our patients have
experienced due to the unforeseen problems. We are profoundly
distressed by this situation and are making every effort to handle
the problem openly, honestly and responsibly." |
| Sulzer
Orthopedics can no longer maintain its formerly expressed opinion
that it is sufficiently insured. The company is committed to a fair
reimbursement of all medical expenses, lost wages and pain and
suffering incurred by the affected patients. |
| The
number of revision surgeries performed on a weekly basis continues
to decline. The Company believes that most of the problems
experienced by patients have occurred within the first six months
after receiving their implants. Sulzer Orthopedics initiated the
recall on December 5, 2000, and based on revision data received to
date, expects that the most critical period since implantation has
passed. However, the Company is not in a position to make a
prediction on the final number of revision surgeries. |
| Ongoing
Scientific Investigations |
| Inter-Op |
| In
connection with the Inter-Op recall, Sulzer Orthopedics has
continued to investigate the issue, utilizing the full expertise and
counsel of physicians as well as internal and external scientists
and engineers. The investigation appeared to reveal that a trace of
mineral oil-based lubricant remaining on the implant after the
manufacturing process was responsible for the lack of proper bonding
between the implant and the bone, in some cases. |
There
still remains some uncertainty about various possible elements that
might have contributed to the unfortunate need for revision surgery
in the hip implant cases. In addition to the mineral oil itself, the
Company is also focusing its investigation on elements within the
mineral oil-based lubricant.
Sulzer Orthopedics has implemented manufacturing and cleaning steps
that are crucial to preventing the problem from recurring. |
| Situation
with other products |
| Sulzer
Orthopedics has tested manufacturing processes and is reviewing
clinical outcomes relating to its porous coated products and is
taking any report of a potential problem seriously. Within that
context, the Company has informed the FDA of its ongoing
investigations of a porous-coated tibial baseplate that was
manufactured from July to December 2000. A few clinical incidences
have been reported so far and investigations are non-conclusive. The
Company is also in the process of informing the very limited number
of surgeons that have implanted that device. The affected
porous-coated tibial baseplates, which are no longer on the market,
were implanted in 1485 patients globally, that is, 1336 patients in
the U.S., 97 patients in Europe, and 52 in Australia. |
| The
investigation of all other Sulzer Orthopedics porous-coated products
showed that they are not affected because they are produced in a
different production process and have reported successful clinical
outcomes. |
| Sulzer
Orthopedics Inc. develops, manufactures and markets products for the
joint and fracture care markets worldwide. The Company's product
offering includes joint prostheses for hip, knee and upper
extremities including instruments as well as fracture care products. |
| 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. |
|
| Source/Contact: |
Sulzer
Medica
|
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