Stryker Trident Hip Recall
Stryker’s Trident hip replacement, once the manufacturer’s bestselling hip implant, was the subject of multiple FDA warnings and patient complaints by 2008. Implant recipients reported squeaky joints, bone fractures, failed implants and other concerns, while the FDA cited manufacturing plant contamination, implant failure, improper documentation, and other issues.
In January 2008, the company issued a Stryker Trident hip recall for two of the system’s component parts. Some Trident hip recipients have filed a Stryker hip lawsuit to seek damages for their injuries.
Stryker Trident hip problems
Reports to the FDA of Stryker hip complications began as early as 2005. Among patient complaints:
- Implant failure (device corrosion, broken component parts, uneven bone wear)
- Bone fractures
- Inflammation and pain
- Squeaky joints
- Plant contamination
FDA Stryker hip warning: serious problems with Trident implant
On March 15, 2007, the FDA issued its first warning letter for the Trident Acetabular system. In the letter, the FDA voiced concern over the manufacturer’s Cork, Ireland facility, where the agency had found violations of the Current Good Manufacturing Practice requirements, per the U.S. Code of Federal Regulations.
Among the cited issues were adulterated manufacture, packaging, and storage of the Trident Acetabular System.
On November 28, 2007, the FDA sent its second warning letter, this time citing problems with the company’s manufacturing facilities in Mahwah, New Jersey. The federal agency discovered Staphylococcus (aka “Staph,” a potentially fatal infection) bacteria clusters throughout the plant, and reprimanded Stryker for failing to find the cause of its Staph contamination.
Among other issues, the FDA also rebuked the company for failing to address and correct several problems with the Trident hip implant, including poor adherence to the bone, delamination of the device’s plasma-sprayed coating, and improper implant seating, which can result in bone wear, fracture, or a broken device.
In addition to the FDA’s findings, Stryker’s Trident hip replacement was also plagued by reports of device squeaking. This problem occurred in a high number of patients: as they walked, their hips emitted squeaking, popping and other troubling noises.
For many, these sounds were disruptive and embarrassing, but even more serious were concerns that the unusual sounds could indicate a bigger problem – possible implant shattering. In the event that the implant shattered, experts worried that the prosthesis could send ceramic shards into the patient’s tissues, causing catastrophic damage.
2008 Stryker Trident hip recall
On January 28, 2008, less than a year after the FDA’s first warning letter, a Stryker Trident hip recall was issued for ceramic hip components manufactured at the company’s Cork facility, and included the Trident Hemispherical Cups and the Trident Acetabular PSL cup, at the time the most common Stryker hip component sold in the United States.
The recall implicated thousands of hip replacements throughout the country. Some injured parties, including those patients forced to undergo costly and dangerous revision surgery, chose to file a Stryker hip lawsuit.
Qualifying Stryker hip complaints for the Trident system have been centralized under Judge Carol Higbee, who presides over the New Jersey Superior Court of Atlantic County.