In 2008, Stryker Orthopedics recalled the Stryker Trident hip implant, a ceramic-on-ceramic hip replacement. The recall came after years of continuous complaints and several warning letters from the U.S. Food and Drug Administration (FDA). Reported problems include loosening, squeaking, severe pain, bone fractures, decreased mobility, and revision surgery.
UPDATE: Stryker Trident Hip Implant Class Action Lawsuit Filed
September 2012 — Lawyers in Massachusetts have filed a Stryker Trident hip class action lawsuit in the U.S. District Court for the Southern District of Massachusetts. The plaintiff, Raymond Chasse Jr., is joined by more than 40 other people who were injured when their Trident hip implant caused pain, discomfort, squeaking, or required revision surgery.
Stryker Trident and Squeaky Hip Implants
The Stryker Trident hip implant is a hip replacement system designed with ceramic-on-ceramic components. The ceramic is medical-grade alumina, which is made from fine-grained, extremely hard material. When the patient moves, a ceramic femoral head pivots inside a ceramic acetabular cup inside the pelvis.
The problem with the Stryker Trident is that many patients develop an excessively squeaky hip implant. In patients who have had their hip implants removed, doctors have found a distinctive pattern of wear, called “stripe wear,” that is caused by excessive force on a poorly-designed implant. It is caused by normal activities, such as walking, climbing stairs, or getting up from a chair.
Although squeaking is a potential side effect of all hip implants, it was relatively rare before Stryker began marketing the Trident in 2003. According to a study published in 2007 by the Journal of Arthroplasty, 10 out of 143 patients (7%) who had a ceramic-on-ceramic hip implant between 2003 and 2005 suffered from a squeaky hip.
The squeaking can be extremely loud — as demonstrated in this YouTube clip uploaded by a patient implanted with a defective Trident. The squeaking may be a sign of early failure, and many patients have required revision surgery to replace their implant.
FDA Stryker Trident Warning Letters
The U.S. Food and Drug Administration (FDA) has sent Stryker several warning letters for problems with the Trident. The first Stryker Trident Warning Letter was sent in March 2007. The FDA found that the Trident manufacturing facility in Cork, Ireland was not in compliance with Current Good Manufacturing Practices (CGMP) standards. These problems were not resolved until March 2010.
The FDA also sent a Warning Letter on November 28, 2007 after finding:
“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
On January 22, 2008, Stryker recalled the Trident hip implant, citing concerns that “manufacturing residuals” could cause contamination.
Stryker Trident hip implants recalls in 2008:
- Trident Acetabular PSL Cup
- Trident Hemispherical Cups
Stryker Trident Hip Implant Side Effects
- Squeaky or loose hip
- Unusual sounds (popping, clicking, grinding, etc.)
- Bone fracture
- Chipping or broken implant
- Uneven wear (“stripe wear”)
- Joint discomfort
- Chronic pain
- Problems walking
- Surgery to replace implant (revision surgery)
- Permanent disability
- And more