Stryker Recalls Hip Implants
Stryker Orthopaedics, one of the world’s leaders in knee and hip implant replacements, recalled two of its hip products in July of 2012 after data showed higher than expected rates of complication and failure. A few months earlier, Stryker sent an Urgent Field Safety Notice to doctors, informing them that parts of the implants were becoming loose and rubbing against each other, releasing metal particles into the blood and surrounding tissue. This shedding resulted in inflammation, tissue damage, bone damage, bone loss, and chronic pain.
Stryker’s hip implants are different from other companies’ implants in that they are marketed as systems made up of interchangeable components that allow doctors to customize each piece to best fit the patient.
In addition, they are made of a proprietary titanium blend that was supposed to resist corrosion and fretting. Fretting occurs when small metal particles flake off into the bloodstream and soft tissue.
The following is a timeline of Stryker’s clearance and recalls:
June 2008: Stryker’s Rejuvenate Modular System was approved through the FDA’s 510(k) approval process.
November 2009: Stryker’s ABG II System was approved through the 510(k) approval process, though the predicate device cited for clearance was already having its own problems.
April 2012: Stryker issues its Urgent Field Safety Alert.
July 2012: Stryker recalls both the Rejuvenate and ABG II devices and faces thousands of lawsuits.
The main problem that was reported time and time again with Stryker’s products was Adverse Local Tissue Reaction, in which metal particles from the implants cause damage to the bone and tissue surrounding the implant and joint. This can lead to:
- Metallosis, or metal toxicity
- Osteolysis, or bone dissolution
- Pseudotumor formation
- Pain requiring revision surgery
- Weakening bones resulting in bone fractures
- Extensive damage to surrounding nerves and tissue
Have you or a loved one received a Stryker hip implant and suffered complications? You can join the thousands who have filed lawsuits against Stryker. Though Stryker will reimburse patients for revision surgeries, in almost all cases, you will receive more thorough compensation by pursuing a lawsuit. Contact a medical device attorney at Kirkendall Dwyer LLP for information.