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Richard R. Schlueter
Richard R. Schlueter
Attorney • (800) 641-0098

FDA Tracks Ongoing Optetrak Issues as Exactech Releases New Knee Replacement Product

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In an effort to provide surgeons with an all-inclusive range of knee replacement systems, Exactech has recently announced the launch of their ExactechGPS TKA Plus—a software application that provides computer guidance within the body for orthopedic surgeons performing total knee arthroplasty (TKA) procedures. The new software—TKA Plus—is technically an add-on to the existing computer system, ExactechGPS, that has already been used in over 8500 knee replacement surgeries.

Of course, this is just a drop in the bucket when compared to the total number of knee replacement surgeries performed on Americans—more than 600,000 each year. And this number is expected to increase during the next decade as one of the largest generations continues to age. Medical device manufacturers are looking to quickly establish their place in the market, but one must wonder if they are circumventing safety and potentially compromising a patient’s quality of life in the process.

While the ExactechGPS TKA Plus system is too new to have received any complaints yet, the FDA has recently made several warnings in regards to accuracy errors associated with other computer-assisted navigation systems—including Medtronic’s NavLock Tracker that’s used in brain and spinal surgery. Additionally, Exactech’s Optetrak knee component [specifically devices manufactured in 2011-2012] has shown evidence of failure due to a “finned” tibial tray that does not allow for adequate adherence to the patient’s bone. The FDA has received numerous reports of early device failure—many requiring revision surgery and device replacement.

 

Could Your Knee Replacement Be Failing?

Within the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, Exactech Optetrak patients have complained of:

  • Pain and swelling in the knee area
  • Instability and loss of mobility
  • Visible loosening of the device
  • Presence of fluid, redness and inflammation
  • Required surgical revision due to loosening

 

Most knee replacement surgeries give the recipients years of improved function with fewer problems and less painbut not always. If you or a family member has experienced such issues or other complications from an Optetrak knee component, our law firm of Childers, Schlueter & Smith might be able to help as we continue to investigate the connection between premature knee failure and Exactech products. If you have questions, please give us a call at 1-800-641-0098. All initial inquiries are free of charge and without obligation.