Medical devices are widely used to replace poorly functioning body systems. One of the most common of these devices is the hip implant. Hip replacement surgeries involve the removal of the poorly functioning hip system and replacing it with an artificial system, in an effort to decrease pain and improve mobility for the patient. However, some hip replacement patients end up with an implant that causes further discomfort and pain. This has found to be the case with Stryker Corporation's Trident Acetabular PSL and Hemispherical Cups used in their implants.
Stryker Corporation, based in Kalamazoo, Michigan, is a medical device and equipment manufacturer that develops and produces medical implants, such as hip implants, as well as imaging and surgical technologies, and, patient handling and emergency medical equipment.
The Trident system is a total hip replacement system surgically implanted to completely replace a dysfunctional or diseased hip joint. The implant involves the implantation of a femoral stem, or stiff rod inserted into the femur (thigh bone), to which the femoral head, or ball-shaped part of the joint, is attached. That then fits into the cup-shaped part of the joint, in this case the acetabular or hemispherical cup, which is implanted into the socket portion of the hip. The femoral head and the ceramic cup fit together and are free to move against each other. Ideally, this would occur without any problems, but such is not the case.
Many patients who received the Trident acetabular PSL cup or hemispherical cup implant have experienced grinding sensations and noises; the grinding could jeopardize the structural integrity of the ceramic-on-ceramic implant. Additionally patients have experienced pain and further discomfort leading to limited mobility. In extreme cases, a patient may suffer serious infection associated with the implant failure. The only option for these patients is the surgical removal and replacement of the implant.
Reports of issues with the implants led to multiple warning letters from the U.S. Food and Drug Administration (FDA), indicating that an inspection of Stryker facilities revealed non-compliance with certain FDA quality and manufacturing standards which could have led to the contamination of the failing hip implants. As a result, Stryker recalled the hip implants in January 2008, after which followed another warning letter targeted at its Hopkinton, MA facility.
Product manufacturers, especially those that develop and produce medical devices, have a responsibility to perform their duties to the highest degree of care. This means that the sterility and safety of their devices must be of the utmost importance. Contamination of a medical device that a patient depends on to improve their health and well being can not only cause the necessary implant to fail, but can lead to serious complications and additional surgeries for the patient.
If you or a loved one has suffered injury as the result of Stryker hip implant failure, you may be entitled to pursue a claim for the losses you have suffered. To determine whether you may have meritorious claim, contact the experienced New Jersey defective product attorneys at Blume Forte at (973) 635-5400. We can investigate your potential claim, and, help you understand your legal rights and options.
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