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It’s no secret that medical device manufacturers would rather tout their successes than reveal problems that have been uncovered with their products. Stryker Corporation’s recent recall of its Trident PSL and Hemispherical Acetabular Cups are causing patients to ask, “When did Stryker know about problems with its hip implant products?”

What the FDA claims

According to the Food and Drug Administration (FDA), Stryker was aware of customer complaints about its Trident line of ceramic-on-ceramic hip implant products since 2005. In a letter released on January 15th of 2008, the FDA warned Stryker to address the issues concerning these products and provided the following information:

According to the letter, the FDA claims that Stryker received the following complaints from patients:

• January of 2005 through June of 2007: Improper seating of hip implants in broached bones resulting in bone fractures.
• January of 2005 through May of 2007: Trident Hemispherical and Trident PSL Cups failed to function; hip implant components have poor fixation. In some instances, these problems have required revision surgeries.
• January of 2005 through April of 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).

What prominent doctors claim

According to Douglass Kreis, a Florida attorney whose firm has been following the Stryker controversy, at least three prominent doctors have confirmed much of the data that is only now being made public. Kreis told us that these doctors expressed serious concern about ceramic-on-ceramic implant products in 2006. Kreis provided the following information:

1. At a conference in late 2006, at which many of the orthopedic surgeons around the country and world convened to talk about various issues, problems and technologies, discussion about the squeaking phenomenon surfaced during several podium speeches and creating a fire-storm of discussion. At this meeting, Dr. Christopher Jarrett raised the issue of ceramic-on-ceramic Trident devices resulting in audible noises or squeaks. Other doctors at the conference reported having the same experience with their patients.
2. Coinciding almost exactly with this late 2006 conference, Italian surgeon Toni Aldo published a study entitled Early Diagnosis of Ceramic Liner Fracture in the Journal of Bone and Joint Surgery in late 2006. The study concluded that cup component enhanced the risk of impingement and the liner fractures.
   
   It revealed that squeaks from ceramic total hips were likely to be a precursor to hip failure and advised that early diagnosis of a ceramic liner fracture is desirable to avoid a wide spread of ceramic particles in the periarticular space (the space surrounding a joint).
   
   However, it further advised that a complication exists in choosing revision surgery after ceramic-on-ceramic failure where ceramic fragments have spread into the periarticular space given the abrasive character of the surrounding tissue and possibility of leading to early failure of the revision procedure.

FDA says Stryker hasn’t done enough

It seems clear that Stryker knew, or should have known, about the problems that patients were experiencing with their Trident hip implants as early as 2005. However, according to the FDA’s most recent letter to Stryker on November 28th, 2007 (made public January 15th, 2008), Stryker has “failed to implement adequate corrective and preventive actions . . . in order to prevent the recurrence of nonconforming product and other quality problems.”

If you are experiencing problems with Stryker’s Trident PSL and Hemispherical Acetabular Cups, contact an experienced attorney who has been following this issue to discuss your situation. For a free, no-obligation consultation, please click here.