FDA Sends Stryker Warning Letter Over Hip Manufacturing Problems

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. SOURCE: Newsday