Stryker Hip Implants, first introduced in 2003, have come under fire by the U.S. Food and Drug Administration (FDA), following complaints of squeaky ceramic hip joints, among other problems.
In 2007, the FDA inspected Stryker’s manufacturing facility in Mahwah, New Jersey, and as a result compiled a lengthy list of problems. Among them the FDA cited Stryker for "Failure 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."
The result was the FDA sending a stern warning letter to Stryker in November 2007 warning them to immediately correct the problems, or the agency would begin to seize property, file injunctions and award not award contracts to the company based on the issues discovered.
Stryker Recalls
Information released by the FDA to the public in November 2008, showed some Stryker hip implants were defective. The agency received several complaints concerning the hip implants from patients that experienced pain, fractures, fragments, bone fractures and more. Many of these issues lead to the patient suffering revision surgery.
Most recently the company recalled two products within its Trident Line in January 2008. The recall involved the Trident Acetabular PSL Cup and the Trident Hemispherical Cups. Interestingly, neither of these recalls was directly related to the problems discovered during the investigation at Stryker’s manufacturing plant the year prior.
If you have a hip implant an experience any of the below problems, please contact your doctor immediately:
Broken bones and/or bone fractures
Chipping and breaking
Discomfort and pain
Difficulty walking
Squeaky or noisy hip implants
Visit the FDA Web site for more information on Stryker recalls as well as other medical device recalls and warning letters.
