Hundreds of thousands of patients have been implanted with Exactech Knee replacements systems since the devices were first introduced to the market. However, many of these systems have dangerous design defects which prompted the companies and the Food and Drug Administration (FDA) to issue warnings and for Exactech to recall the potentially dangerous products, including the Exactech Optetrak, Truliant and Logic Knee replacement systems. Thousands of patients have experienced complicated problems, including component fatigue and breakdown, bone loss and cracking, and accelerated knee wear, causing early painful revision surgery to correct the problems.
Defective polyethylene inserts, which are utilized in knee replacement surgeries are wearing out and degrading prematurely, resulting in necessary knee revision surgeries. In February 2022, Exactech issued a recall for more than 147,000 knee, ankle and hip implants used since 2004. The FDA has also issued recalls after receiving numerous reports of knee implant failures.
On February 7, 2022, an Exactech knee replacement recall notice was sent to orthopedic surgeons throughout the United States, providing information about over 100,000 defective and dangerous knee inserts implanted in patients starting in 2004. The manufacturer also provided this recall letter that should be sent to all individuals who had the defective device impacted. Although most consumers didn’t learn about this recall until 2022, the manufacturer first disclosed problems with the replacement inserts in an August 2021 recall to over 60,000 patients. The recall has now been substantially expanded to include Exactech Optetrak knee replacements sold since 2004, Logic knee implants sold since 2009, and Truliant knee systems sold since 2017.
Originally introduced in the United States in 1994, the manufacturer’s implant was on the market for about ten years before any significant changes were introduced. These changes were made to the manufacturing process for vacuum bags used for polyethylene inserts with these knee implants, which is the reason for the extensive recall.
Most of this manufacturers knee implants sold since 2004 have been recalled, including: