The lawsuit was filed by Marcus Talley, a man who accuses Exactech Inc. of selling a defective knee replacement despite knowledge that the Optetrak® was failing at an unreasonable rate.
Talley was implanted with an Exactech Optetrak after undergoing total knee replacement surgery. He required another surgery when the implant failed prematurely when the tibial tray component loosened.
Talley accuses Exactech of engaging in a “silent recall” by slowly removing the Optetrak’s finned tibial tray components from the market and replacing them with a sturdier design called “fit” tibial trays. According to the lawsuit:
Despite Defendants knowledge of early onset failures of the Optetrak knee implants and the increased risk of failure for overweight and obese patients, Defendants never alerted the FDA of the known increased risks.”
Reports indicate that many people have required revision due to loose tibial components, aseptic loosening, pain, limited mobility, knee swelling, and sensitivity due to loosening of the knee joint.
Exactech has been selling the Optetrak knee replacement system since 1994, but the design was slightly changed in 2011 and 2012. Unfortunately, studies soon showed that the new “finned” tibial trays were not adequately bonding to the patient’s knee bones.
In 2012, a study of 110 patients with the Exactech Optetrak knee replacement warned about “poor results” and high failure rates — 12% of patients needed another surgery within 5 years, 20% of patients needed routine painkillers, and another 22% of the implants were “evolving toward tibial implant loosening.”
All of the versions of the Optetrak were approved through the FDA’s 510(k) approval process, which means they were allowed on the market because they were “substantially equivalent” to existing devices, so they did not have to undergo extensive safety testing.
The lawsuit was filed on October 11, 2017 in the U.S. District Court for the Northern District of Alabama — In RE: Marcus H. Talley v. Exactech Inc — Case No. 2:17-cv-01735-RDP.