A warning letter issued by the FDA on August 19, 2010 to DePuy Orthopaedics cites numerous cases where DePuy marketed two hip replacement systems without the required marketing clearance or approval. The two systems in question are the TruMatch Peronsalized Solutions System and the Corail Hip System.
The TruMatch system had not been cleared to be marketed at all. The device has not received its premarket approval nor has it received an approved application for investigational device exemption.
DePuy is under fire for marketing the Corail Hip system in ways that were unapproved by the FDA. The illegal marketing could lead to misuse of the device as well as surgical techniques not approved by the FDA.
If you have a DePuy hip replacement system and have had a revision or are experiencing pain you associate with it, contact an attorney at Rheingold, Giuffra, Ruffo & Plotkin LLP to speak with an experienced product liability lawyer.