FDA Issues Warning to Manufacturer of Artificial Hip Devices
The Food and Drug Administration (FDA) issued a second warning letter to Stryker Orthopedics Corp. about problems associated with the company’s hip implants.
The FDA warning letter to Stryker, dated November 28, 2007, came after FDA officials spent six weeks last summer inspecting the company’s orthopedics division located in Mahwah, New Jersey. At that time, FDA investigators found a number of deficiencies that the company has since failed to address.
“Your firm has failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems,” warns the FDA letter.
Specifically, the FDA cited complaints received between 2005 and 2007 concerning:
- Failures in Stryker’s Trident Hemispherical and Trident PSL cups and hip implant components, which resulted in improper fitting of hip implants that cause bone fractures
- Pain and difficulty walking
- Parts breaking off or wearing down unevenly
According to the FDA, some of those problems required that patients undergo additional surgery to correct. To see the complete FDA letter,
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