The DePuy Pinnacle System was launched to the marketplace in 2000. It was designed and released by Johnson & Johnson’s orthopaedics subsidiary, DePuy. It was intended to be marketed towards younger patients as a more durable option.
Recent studies from several sources have shown severe negative side effects from using metal on metal hip implants, including the DePuy Pinnacle Systems, including metal poisoning and significant failure rates within only a few years of implantation.
Facts about DePuy Pinnacle Hip Replacement Systems:
- The system was cleared by the FDA through the 510(k) process, a process which allows a manufacturer to obtain market approval with very little clinical testing of the device if it resembles a product already in use.
- On May 6, 2011 the FDA issued orders for post-market surveillance studies to manufacturers of metal-on-metal hip systems. The FDA sent 145 orders to 21 manufacturers. Manufacturers will be required to submit a research protocol to the FDA that addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles.
- This failure had the potential to cause cobalt and chromium poisoning; a type of metal poisoning that can cause complications such as tumors, brain trouble and heart failure.
- The first lawsuit was filed on June 15, 2010.
- In May 2011, the Judicial Panel on Multidistrict Litigation approved of creating a separately consolidated DePuy Pinnacle hip litigation in addition to the federal DePuy ASR MDL currently set in the Northern District of Ohio.
- The DePuy Pinnacle lawsuit MDL in Northern Texas is now advancing through a series of pre-trial status conferences. A first trial date has yet to be set by Judge Kinkeade.
If you or a loved one have or had a DePuy Pinnacle Hip Replacement System and suffer from heavy metal poisoning, metallosis, required early revision, or suffered from elevated blood cobalt and/or chromium levels, find out how Johnson//Becker PLLC can help you. Fill out our case review form here on our website and submit it for a free consultation.