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

MAUDE Database Points to Problems with Exactech’s Optetrak Replacement Knee

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First established in the early nineties, the Manufacturer and User Facility Device Experience—or MAUDE—database is mandated reporting system maintained by the Food and Drug Administration that allows for the posting of any event in which medical devices may have malfunctioned, caused injury or even death. Available both to the medical community and the general public, the MAUDE database offers valuable insight into the observed performance of currently used medical devices.

While the last report of an adverse event involving the Optetrak replacement knee was in June 2017, it is only the latest in what amounts to overwhelming evidence of a product issue. With some of the earliest reports dating back to 2011, there were 231 adverse event reports involving the Exactech device in 2015 alone, and 160 reports in 2016.

The U.S. Could See 3 Million Knee Replacement Surgeries a Year by 2030

Such high numbers coincide with the increase in the number of people opting for knee replacement. Currently, more than 600,000 Americans have the surgery each year—making it the most prevalent procedure performed on patients aged 45 years and older. The number is expected to grow as the Baby Boomer generation continues to age. Yet, problems could persist for those whose doctors have chosen the Optetrak knee component that were specifically manufactured during 2011 and 2012 as they have been shown to fail due to a “finned” tibial tray that was later corrected on subsequent models. It is speculated that the finned design does not allow for adequate adherence to the patient’s bone, and problems ranging from loosening of the device to instability caused by detachment have been reported.

Your knee replacement could be failing—requiring revision surgery and device replacement. You should have your specific situation assessed if you are experiencing any of the following:

 

  • 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

 

You Shouldn’t Have to Suffer Due to a Defectively Designed Component

While most knee replacement surgeries offer years of improved function with reduced pain, there is always the potential for product failure. Manufacturers will often offer a correction, but this is usually a painful process at the inconvenience of the patient. 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.

 

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