After suffering Pinnacle hip implant complications, an injured consumer recently filed a lawsuit against DePuy accusing the company of manufacturing a defective product.

Plaintiff Anne Z. filed her lawsuit against DePuy and Johnson & Johnson after reportedly experiencing a variety of Pinnacle hip implant complications.

Anne says she was implanted with the Pinnacle hip replacement in December 2008.  However, she allegedly began experiencing hip replacement problems including severe pain, inflammation, and discomfort. These Pinnacle hip implant complications lead to her eventual revision surgery in October 2013, she claims.

A metal-on-metal hip replacement system, the Pinnacle hip implant was designed to provide pain relief and a consistent, smooth range of motion for joints damaged by fracture, osteoarthritis, rheumatoid arthritis, and avascular necrosis. DePuy reportedly markets the Pinnacle hip replacement system as “[u]niquely designed to meet the demands of active patients like you –and help reduce pain”. The company points to the device’s “TrueGlide” technology, which reportedly creates a thin film of lubrication between surfaces that creates “a more fluid range of natural motion.”

However, Anne alleges that the Pinnacle hip replacement system is defective and prone to issues. These complications are reportedly caused by the implant releasing metallic particles into the joint. This reportedly causes various Pinnacle hip implant complications including metallosis, tissue death, bone erosion, inflammation, pain, and development of tumors.

DePuy Hip Complaints

Anne’s lawsuit points out, “On information and belief, Plaintiff alleges that over 1,300 adverse reports have been submitted to the U.S. Food and Drug Administration (FDA) regarding failures or complications of the Pinnacle Device.” The Pinnacle hip implant claim adds that the “Plaintiff further alleges that Defendants are aware that certain Pinnacle Device recipients have elevated cobalt and chromium levels greatly exceeding acceptable safety standards.”

The Pinnacle lawsuit claims that DePuy never actually conducted clinical trials for the hip replacement system because it was approved through the FDA’s 510(k) approval process. The 510(k) process allows for approval of devices if they can be shown to be sufficiently similar to an existing, approved device already on the market. The Pinnacle was allegedly shown to be “substantially equivalent” to an older device which DePuy sold before the Medical Device Amendments to the Food, Drug, and Cosmetics Act in 1976.

Anne argues that, had DePuy performed clinical testing before gaining approval for the device, they would have learned that the device is prone to early failure and can cause a variety of injuries. Anne also claims that she and her doctor would not have chosen to use the Pinnacle hip replacement system if they were aware of the early failure rate, risks, and Pinnacle hip implant complications caused by the device.

The lawsuit accuses DePuy and Johnson & Johnson of negligence, manufacturing defect, design defect, inadequate warning, breach of express warranty, breach of implied warranty of merchantability, negligent misrepresentation, and fraud. Anne seeks compensation for economic and non-economic losses, punitive damages, court costs, and attorneys’ fees.

The Pinnacle Hip Implant Complications Lawsuit is Case No. 3:18-cv-02650-K in the United States District Court for the Northern District of Texas.