Stryker Orthopedics recalled the Trident ceramic hip replacement system in 2008 after receiving numerous reports of loosening and squeaking. Patients who have problems with a Stryker Trident hip implant may not be able to perform normal daily activities due to severe pain or decreased mobility. They may also need revision surgery to remove and replace the defective hip implant.
UPDATE: Stryker Trident Hip Implant Class Action Lawsuit Filed
September 21, 2012 — The Stryker Trident hip class action lawsuit was filed in the U.S. District Court for the District of Massachusetts by plaintiff Raymond Chasse, Jr., seeking to represent all Massachusetts residents who were injured by pain, discomfort, or squeaking caused by this defective hip implant. At least 40 people have joined the lawsuit.
Stryker Trident and Squeaky Hip Implants
Stryker Trident hip implants are designed with ceramic-on-ceramic parts, in which a ceramic femoral head pivots inside a ceramic cup attached to the patient’s pelvis. These parts are made of very hard, fine-grained medical ceramic called alumina.
Over time, a distinctive pattern of wear, called “stripe wear,” has been found in patients who developed squeaky hip implants (as demonstrated in this YouTube clip). This type of wear occurs naturally during normal daily activities, such as walking, getting up from a chair, or walking up stairs.
Artificial hips can occasionally make unusual noises, but squeaking was relatively uncommon before Stryker created the Trident in 2003. In 2007, a study published in the Journal of Arthroplasty found that squeaking occurred in 10 out of 143 patients (7%) who received ceramic hips between 2003 and 2005.
The squeaking can be extremely loud, embarrassing, and debilitating for normal daily activities. Furthermore, it may be a sign of premature wearing. As a result, many patients have required revision surgery to remove and replace their hip implant. The problem with a second surgery is that it can be more traumatic at an older age, expensive, with a long recovery time.
FDA Stryker Trident Warning Letter
On March 15, 2007, the U.S. Food and Drug Administration (FDA) sent a Stryker Trident Warning Letter after an inspection of the company’s manufacturing facility in Cork, Ireland found that the Trident hip implants were not manufactured in conformity with Current Good Manufacturing Practice (CGMP) requirements. Two years later, in March 2010, Stryker announced that the issues were resolved and the company was in compliance with FDA manufacturing standards.
The problems with the Trident continued in an additional Warning Letter the FDA sent Stryker on November 28, 2007:
“Your firm received continual complaints [from 2005 to 2007] … squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments). … complaints for improper seating of hip implants in broached bones resulting in bone fractures. Your firm has failed to implement adequate corrective and preventive actions.”
2008 Stryker Hip Implant Recall for Trident
In response to the FDA warning letters, in January 2008 Stryker announced that it was recalling two hip implant components under the Trident line over concerns that “manufacturing residuals” may have contaminated the products.
Recalled Stryker Trident hip implants include:
- Trident Acetabular PSL Cup
- Trident Hemispherical Cups
Hip Implant Side Effects
- Implant failure
- Corrosion of parts
- Broken components
- Uneven wear (“stripe wear”)
- Bone fractures
- Joint pain or discomfort
- Squeaky joints
- Loosening of the joint
- Abnormal sounds (popping, clicking, grinding, etc.)
- Difficulty walking
- Need for revision surgery
- And more