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Hip Implants and the FDA
The U.S. Food and Drug Administration (FDA) issues safety alerts and recalls when a product poses risks to consumers. The agency has issued several safety alerts and recalls involving defective hip implants and other dangerous medical devices.
The FDA has three categories of published warnings:
- Mislabeling of contents
- Product safety alerts, including warning letters
- Recalls of products
The above categories are listed in order of increasing severity.
Hip Implant Recalls
A number of hip prostheses, including those already implanted in patients, have been recalled. Patients from around the world are filing lawsuits against the makers of the recalled implants, seeking compensation for the cost of revision surgery, lost wages and pain and suffering.
Companies that have issued recalls on hip implants include DePuy Orthopaedics, Zimmer, Inc. and Stryker Corporation, among others. Hip implants are recalled if they fail at a higher than normal rate and require that a large number of patients receive a second surgery to fix or replace the failed implant.
DePuy Hip Implant Recall
DePuy Orthopaedics, a Johnson & Johnson company, recalled two hip replacement systems in August 2010:
- ASR™ XL Acetabular System, a total hip replacement device.
- ASR™ Hip Resurfacing System, a partial hip replacement in which a metal cap is placed on the ball of the femur (thigh bone), a method intended to preserve more of the patient's own bone.
According to the DePuy recall, approximately 12 to 13 percent of patients had hip implants failures within 5 years of their surgeries and needed to have revision surgery (another operation).
Zimmer Durom Cup Recalled
Zimmer, Inc., headquartered in Warsaw, Indiana, makes prosthetic products for hips, knees, shoulders, elbows, the spine and trauma and dental products. In 2008, Zimmer suspended sales of the Durom Replacement Acetabular Components, or the Zimmer Durom Cup, after hundreds of patients needed revision surgery.
Stryker Hip Implant Recall
Stryker Corporation manufactures products including implants used in joint replacement, trauma and spinal surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment, in addition to other medical device products. The FDA inspected its manufacturing plants in Mahwah, New Jersey, and Cork Ireland.
Two Stryker hip implants were recalled in January 2008:
- Trident Acetabular PSL cup
- Trident Hemispherical Acetabular cup
The FDA recalled the devices due to concerns regarding lack of proper sterility at the manufacturing plants in New Jersey and Ireland. The FDA had previously issued two warning letters to Stryker about its manufacturing facilities.
Patients with Stryker implants had been complaining since 2005 of problems with their prostheses. The complaints included popping and clicking noises made by the implants and pain. Some of the implants had shattered inside the patients' bodies, requiring revision surgery.
Contact one of our defective hip lawyers today if you wish to seek compensation for a failed hip replacement.