DePuy Pinnacle Lawsuit
DePuy Pinnacle Hip Lawsuit History
The Pinnacle hip replacement is a total hip replacement system manufactured by Johnson & Johnson subsidiary, DePuy Orthopaedics. Approved by the U.S. Food and Drug Administration (“FDA”) in 2000, the DePuy Pinnacle Hip Acetabular Cup System was the predecessor to the now recalled DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System. The DePuy Pinnacle hip replacement is a total hip arthroplasty intended to provide increased mobility while reducing pain in patients with damaged hip joints. Like patients who received ASR hip replacements, it appears that those who received the DePuy Pinnacle hip replacement also face an increased risk of hip failure. This is because the two hip replacement systems have similar design defects, which can lead to severe pain, dislocation of the hip implant and hip replacement failure. Although the DePuy Pinnacle implants were not part of the August 2010 DePuy ASR hip recall, they are also metal-on-metal devices, and therefore carry many of the adverse side effects commonly experienced by ASR hip implant recipients. Due to the defective design associated with metal-on-metal implants, as with the ASR hip systems, many recipients of DePuy Pinnacle hip replacement implants have had to undergo painful revision surgeries. Thus, a DePuy Pinnacle recall could be issued in the future.
DePuy Pinnacle Hip Replacement Side Effects
Common side effects associated with DePuy Pinnacle hip replacement implants include:
- Pain in the groin, hip or leg
- Swelling and inflammation
Additionally, patients who received the DePuy Pinnacle hip implants should be aware of symptoms associated with metal toxicity, or metallosis. The effects of metallosis can manifest outside of the hip region. Therefore, individuals who received a DePuy Pinnacle hip replacement should be mindful of any changes in their overall health and pay close attention to any symptoms related to their:
- Heart (chest pain, shortness of breath)
- Nerves (numbness, weakness, change in vision or hearing)
- Thyroid (fatigue, feeling cold, weight gain)
- Kidney (change in urination habits)
If you have suffered from any of these symptoms, you may be eligible to file a DePuy Pinnacle lawsuit and should consult with a Pinnacl hip lawyer today.
Pinnacle Hip Systems Approved Through 510(k) Process
Similar to the ASR hip systems, the DePuy Pinnacle hip replacement system received FDA approval through the expedited 510(k) process, which only requires a manufacturer to show that its medical device is substantially similar to devices already available on the market. Manufacturers are able to bypass rigorous pretrial testing and FDA inspection. The DePuy ASR hip implant recall is a prime example as to why the current 510(k) process is flawed and jeopardizes the safety and welfare of the public. If DePuy had been required to undergo the standard approval process, it is probable that the severe hip replacement complications stemming from the metal-on-metal implants would have been detected and the implants would not have been cleared for patient use. Perhaps the DePuy ASR hip implant recall and the disastrous aftermath could have been avoided altogether. Unfortunately, however, the DePuy ASR hip implant was not recalled until 37,000 Americans had already received the defective prosthesis – many of whom are now dealing with serious hip replacement complications. Unless a DePuy Pinnacle recall is issued, thousands more may continue to receive this hip implant, which like the recalled ASR hip implant, was approved without proper testing.