July 24, 2014 — Johnson & Johnson’s DePuy Orthopedics unit has been hit with a lawsuit from a man who says the DePuy Sigma knee implant failed within just 15 months, forcing him to undergo numerous medical procedures and revision surgery.
The lawsuit (PDF) was filed July 1 in the U.S. District Court for the District of Hawaii. The plaintiff, Manuel A. Sanchez, had a knee replacement surgery in March 2011 to treat end-stage arthritis in his left knee. He was implanted with a DePuy Sigma knee replacement, which was fixed using bone cement.
Problems began almost immediately. Two months after the surgery, he was admitted to the hospital with arthrofibrosis, a condition in which scar tissue in the knee decreases flexibility.
In October, he was diagnosed with synovitis, which is a painful inflammation of the membrane around the joint. His doctors also suspected a infection. Fluid was drained from the knee at least seven times, but problems persisted.
After changing doctors, a CT scan showed that the DePuy Sigma knee had rotated and doctors found that a component was loose. In July 2012, Sanchez had revision surgery to remove and replace the implant.
According to the complaint:
“The prosthetic knee components used in Plaintiff’s knee replacement surgery on March 29, 2011 failed to perform as designed and/or were not properly cleaned and/or shipped with a coating that prevented the Palacos cement from affixing to the tibial component which resulted in catastrophic knee failure suffered by Plaintiff.”
This is not the first time concerns have been raised about DePuy knee replacements. In January 2013, DePuy issued a Class I recall for a component of the Limb Preservation System (LPS) knee replacement. The recall was issued after 10 people reported that the implant fractured, loosened, or failed prematurely.