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According to an FDA Warning issued on November 28, 2007 and released to the public on January 15, 2008, some models of Stryker hip implants may be defective. The FDA has received numerous complaints concerning Stryker hip implants from patients experiencing fractures, pain, wear particles, fragments, and broached bones resulting in bone fractures. Many of these problems required revision surgery. This is the second stern warning issued in 2007 by the FDA to Stryker about its implants. The most recent warning letter followed an inspection by the FDA at Stryker’s Mahwah, NJ plant which took place on June 12 and July 1, 2007.

An earlier letter issued in March followed the inspection of a Stryker plant in Ireland where Stryker knee implants are made. According to the FDA, the inspection of the New Jersey plant uncovered problems directly linked to the manufacture of defective hip implant components. Those problems included failing “to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems” related to complaints Stryker received between January 2005 and April 2007, and “verifying or validating the corrective and preventive action to ensure that such action is effective.” The FDA also said that the four responses it received from Stryker regarding the problems found during the NJ inspection were inadequate.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

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