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FDA to Stryker: Fix hip implant flaws
Link to Original Article SNBC
By
LINDA A. JOHNSON updated 5:48 p.m. ET, Wed., Jan. 16, 2008
TRENTON, N.J. - Federal regulators have
ordered medical device maker Stryker Corp. to fix a host of
long-standing problems in its manufacturing of hip
replacement parts that have triggered multiple patient
complaints and forced some to have follow-up surgeries.
Stryker shares fell almost 2 percent.
The U.S. Food and Drug Administration told Kalamazoo,
Mich.-based Stryker in a letter that it was aware that the
company has received patient complaints since January 2005
about a range of problems, including improper fitting of hip
implants that caused bone fractures. Patients also have
complained about pain, difficulty walking and "squeaky"
joins, and some have had pieces of implant parts break off
or wear down unevenly.
The six-page warning letter was prepared after FDA officials
spent six weeks last summer inspecting the company's
orthopedics division headquarters in Mahwah, N.J., which
houses manufacturing operations, research and development
and administrative offices.
The letter discusses deficiencies found during those
inspections and repeatedly states that four company
responses on those issues, sent between Aug. 1 and Nov. 2,
were inadequate for a variety of reasons.
"Your firm has failed to perform corrective and preventive
actions in order to prevent the recurrence of nonconforming
product or other quality problems," the Nov. 28 letter
states repeatedly.
FDA said in the letter that if Stryker does not correct the
violations promptly, FDA can act without notice and seize
property, levy fines and seek injunctions. The letter also
notes that the FDA will not approve sale of certain new
Stryker medical devices until the violations are fixed and
that it will notify federal agencies about the warning
letter, so they can consider it when awarding contracts.
A heavily redacted version of the letter was posted Tuesday
on the agency's Web site.
FDA noted that some parts of the plant were found to be
contaminated with disease-causing germs, including "clumps
and clusters" of a form of Staphylococcus bacteria.
"Your firm has not identified the root causes of the
microorganism contamination and has not executed corrective
and preventive action to prevent recurrence," the letter
states.
Stryker officials declined an interview request from The
Associated Press Wednesday, but provided a prepared
statement.
"We take these matters very seriously and are committed to
developing, manufacturing and marketing medical products
that are safe and effective and that comply with applicable
laws and regulations," it said. "We have been working
diligently for the past several months to respond to the FDA
and will continue to work closely with them to address these
matters."
Stryker was among five companies, which together provide
nearly all replacement hips and knees in the U.S. market,
that in September agreed to pay $310 million and accept
federal monitors to settle allegations they gave doctors
kickbacks to use their products.
Stryker shares fell $1.36, or 1.9 percent, to $69.75 in
trading Wednesday.
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