DePuy Pinnacle Hip Recall

DePuy Orthopaedics originally issued a recall on their DePuy hip replacement systems in September of 2010, due to a number of reports of early failure with the hip replacement systems. Most patients who undergo a hip or knee replacement are told that their implant will provide life-long relief. Since the recall was released, there have been an increasing number of patients reporting problems with their hip implants. Out of a total of 93,000 of these particular hip replacements implanted in patients worldwide, 13% have been reported to be defective. Due to these complications, patients have had to undergo revision or corrective surgery within an average of 5 years of the original implant surgery. A failure in the original design of the hip replacement systems was reported to be the cause of the defects in the systems, and since the original recall, the ASR hip system was the only system reported to the FDA and affected by the recall.

There were two hip systems that have been recalled by Depuy Orthopaedics, the ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System. The ASR XL Acetabular Hip System was commonly used for complete hip replacements whereas the Depuy ASR Hip Resurfacing System was used for bone conserving surgeries. Pain and/or problems walking are the most common problems that begin to surface in the defective systems, but other complications could include blood clots and infections. Depuy Orthopaedics and the FDA both strongly recommend that if a patient experiences any of these symptoms, to discuss it with their doctor and report the issue(s) to the FDA’s Medwatch Program promtly. Typically, the reason for any complications is loosening of the materials in the hip replacement. The parts detach from the bone, resulting in dislocation, which could lead to infection. In cases like this, revision surgery, where the surgeon will replace the implant with a new one, is necessary. Patients can be proactive about watching for symptoms of any complications by following all of their doctor’s aftercare instructions and making follow-up visits. The healthcare specialist can then evaluate the patient’s progress and perform blood tests that could detect unusual metal particles, which could indicate a problem with the implant. Along with working closely with their doctor, the FDA encourages patients who are having extreme problems with their implant to contact an attorney.

Resources

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