Zimmer is being sued by Michael J. Casini, of Granger, for a faulty knee replacement product. According to official court documents filed on Nov. 12, Casini suffered damages as a result of Zimmer’s “development, design, manufacture, distribution and selling of … the Zimmer NexGen CR and the Zimmer NexGen CR-Flex Porous Femoral knee replacement system.”
On Dec. 6, 2009, Casini underwent surgery to have Zimmer’s NexGen Knee implanted in his right knee. Shortly after, he reported experiencing severe and debilitating pain. Casini’s physician advised that he was experiencing “loosening.”
On March 9, 2011, Casini had surgery to revise – or remove and replace – the loosened knee replacement. Not long after that surgery, Casini again began experiencing severe pain.
This was Casini’s second NexGen Knee, and it was also loosening, according to the lawsuit. Casini had to undergo a third surgery on Jan. 24, 2012.
Zimmer’s Next Generation Knee Complete Knee Solution System was released in 1995. Rather than being cemented into place like most knee replacement devices, the implants are designed to naturally fuse to the bones in the leg.
Zimmer’s materials and designs for the NexGen Knee were approved by the FDA. However, in 2010, Dr. Richard A. Berger, a Zimmer consultant, and Dr. Craig J. Della Valle presented a paper at the American Association of Orthopedic Surgeons. The paper stated that nine percent of their patients who had the Zimmer NexGen Knee implanted required revision surgery. Furthermore, 36 percent of their patients showed signs of implant loosening within a year of implantation.
Drugwatch.com reported that Dr. Berger notified Zimmer of the issue, but the company defended its device and blamed the doctor’s surgical technique. By 2007, Dr. Berger stopped offering the knee implant entirely and learned that several other surgeons had also experienced problems with it.
According to court documents, Casini claims Zimmer understated the health hazards and risks associated with the NexGen Knee and marketed the product as a safe knee replacement solution. However, Zimmer’s website reports that the FDA has never ordered a recall on the NexGen Knee.
Cacini, who is represented by Richard Morgan of Sweeney, Pfeifer, Anderson law firm out of South Bend, is suing for strict liability, product liability – failure to warn, product liability – defective design, negligence, breach of express warranty and breach of implied warranty.