FDA to Stryker: Fix hip implant flaws
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
A heavily redacted version of the letter was posted Tuesday on the agency’s Web
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
"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.