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Stryker Corporation’s President and CEO, Stephen P. MacMillan, recently told analysts that the company has “work to do” regarding the problems surrounding its
Trident line of hip implants. The company has been receiving complaints about their products since 2005 – yet little has been done to address the problems so far.
Company not “feeling good”
MacMillan reportedly said that he was “frustrated and disappointed” over the warning letters the company has received from the Food and Drug Administration (FDA) concerning problems at the company’s New Jersey and Cork, Ireland manufacturing facilities. He has been quoted as saying that, “You don't get two letters in nine months and feel good.''
Patient frustration
Patients with Stryker’s Trident PSL and Hemispherical Acetabular Cups have been complaining to the company for years, but have received little in return. The company’s Trident line of hip implants uses ceramic-on-ceramic components rather than metal-on-metal or metal-on-plastic components. This ‘new’ technology – which had been touted as an improvement over older methods – hasn’t seemed to live up to the hype. Patients have complained about pain, difficulty in walking and pieces of the ceramic materials breaking off and wearing unevenly. However, the most frequent complaint seems to be squeaking. While that may seem trivial to some, patients say that it is anything but.
Legal expert explains problems
Douglass Kreis, a Florida attorney whose firm is representing clients, says that the squeaking emanating from the devices raise very serious medical concerns. According to Kreis, patients fall within four general categories relating to the Trident ceramic-on-ceramic implant issues:
Patients with implanted Trident ceramic devices who have yet to experience squeaking or pain but now have reasonable apprehension that they are at risk;
- Patients that have an audible noise and/or pain emanating from such devices;
- The third category includes patients that have experienced squeaking noises and/or pain that have had to undergo further, often painful, revision surgery to have the device replaced; and
- Finally, the fourth category includes those patients who are candidates for revision surgery, but for various reasons, cannot undergo such surgery.
- Kreis explained the type of patients included in the fourth category and their frustration in not being able to correct the problem. He stated, “I have a client with a recently diagnosed heart condition. After her implant, and resulting squeaking and pain, her physicians advised that she was a candidate for revision surgery but could not undergo the same unless her implant completely fractures.”
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.