Stryker Trident PSL and Hemispherical Acetabular Cups
On January 22, 2008, after numerous warning letters from the FDA about failing to establish and maintain procedures that conform to FDA guidelines or adequately address consumer complaints, Stryker Corporation issued a recall of its Trident PSL and Hemispherical Acetabular Cups that did not meet internal specifications.
The FDA warning letters described a range of deficiencies, including "clusters" of Staphylococcus bacteria, the pathogen that causes staph infections, that were found throughout the Stryker facility. In addition, Stryker "failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems." For instance, in regards to the bacterial contamination, Stryker "has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence."
See FDA warning letters to Stryker: Warning letter to New Jersey Facility; Warning Letter to Cork, Ireland Facility
Since September 1999, when these hip devices were first sold, there have been many reports of squeaking, screeching, popping, grinding and other noises coming from the devices. In November 2006, at the annual American Association of Hip and Knee Surgeons fall meeting, several surgeons presented findings related to this squeaking phenomenon. They reported that there was no correlation between cup position and squeaking, and they believed that impingement is a potential cause of the noise.
At present, lawsuits involving Stryker's Trident PSL and Hemispherical Acetabular Cups have been consolidated in New Jersey state court in Atlantic City. Claims of the defective hips include loosening requiring revision surgery and continuous squeaking emanating from the device.
If you or a loved one has a Stryker hip implant and has suffered injuries or problems as a result of the product, please contact the law firm of Pogust Braslow & Millrood, LLC, for a free consultation.
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