Sulzer Knee Replacement Recall
| Defective
Sulzer Knee Implants |
| Sultzer
hip
implants |
|
May 21, 2001 Sultzer press
release |
| June
18, 2001 Sultzer press
release |
|
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
|
|
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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