Recipients of the ceramic-on-ceramic Stryker Trident Hip Replacement System have reported suffering several adverse side effects and hearing unusual squeaking sounds emanating from these devices. In 2007, after finding quality control problems at the Stryker production facilities that manufactured the Trident Hip Replacement, the U.S. Food and Drug Administration (FDA) sent letters to the company, chastising it for failing to resolve the issues that contributed to the Trident’s side effects. A year later, Stryker recalled the Trident Acetabular PSL Cup System and the Trident Hemispherical Cup System and invested a lot of money to bring its facilities up to code.
What Is The Trident Hip Replacement?
Unlike earlier hip replacements made of plastic components, Stryker Corp.’s Trident Hip Replacement is comprised of a ceramic material that researchers developed and named “CeramTec.” In 2008 the New York Times ran an article reporting that manufacturers believed these components were more durable than other materials, making them less likely to break or wear out.
The FDA approved the Trident for sale in 2003, and it did quite well. In another 2008 Times piece, Stryker claimed that it could sell its hips for 50% less than its competitors who used other materials. Due to the side effects the Trident causes, though, its sales dropped, as did sales of ceramic-on-ceramic hips generally.
The Trident Hip Replacement Might Cause Squeaking & Other Side Effects
In the years that followed the Trident’s introduction, recipients began reporting hearing “squeaking” sounds coming from the devices. Others claimed that the devices wore down unevenly with time, or that pieces broke off them altogether. Although Stryker claimed only 1% of its Trident recipients had squeaky hips, a study published in the Journal of Arthroplasty determined that 10 Trident recipients out of 143 (7%) squeaked.
In 2007 the FDA responded to these complaints by inspecting Stryker’s plants in New Jersey and Ireland, and found quality control problems at both facilities. It sent Stryker warning letters in March and November 2007 chastising the company for failing to resolve the issues that contributed to the Trident’s side effects. To remedy these problems, in January 2008 Stryker recalled the Trident Acetabular PSL Cup System and the Trident Hemispherical Cup System and spent $50 million bringing its facilities up to code.
According to the FDA, the Stryker Trident can cause the following side effects:
- Wear particles
- Implant failure
- Improper implant seating contributing to broached bones and bone fractures
Stryker Faces Trident Hip Replacement Lawsuits
Many recipients sued Stryker due to the defects allegedly caused by their Trident hips. Unfortunately, they suffered a setback in February 2011 when the Fifth Circuit Court of Appeals held that the plaintiffs’ lawsuits were barred by a federal doctrine called “preemption,” which disallows product liability claims against manufacturers whose devices receive FDA approval outside of the 510(k) premarket approval process.
However, in November 2012 a federal judge in New York allowed a Trident lawsuit against Stryker to go forward on grounds of product liability, negligence, and loss of consortium between the plaintiff and his spouse. Only the breach of warranty claim was barred by the state’s statute of limitations.
RLG’s Trident Hip Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Stryker Trident hip relacement lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Trident hip lawsuit on your behalf if necessary. RLG will also keep you up to date on any Trident hip class action lawsuits, additional FDA Trident hip warnings, and additional Stryker Trident hip replacement FDA recall announcements.
If you received a Stryker Trident hip replacement and believe it harmed you, contact RLG today.