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Each year, more than 600,000 Americans have knee replacement surgery—a number that many believe will grow to one million within the next 10 years. Baby Boomers, once the largest living generation in history, have continued to age while still wanting to hang on to their active lifestyles. The desire for a medical device that offers more mobility, less pain and a quicker recovery has fueled advancement in the field of knee replacement during the past several decades, but has it been at the expense of patient safety and quality of life?

First started in 1994, medical device manufacturer Exactech is one such company that has been a pioneer in knee replacement. A Gainesville, Florida based company; Exactech has grown into a global presence—but not without pains. In 2010, the company settled with federal prosecutors for $3 million as a result of kickbacks given to orthopedic surgeons. Starting in 2013, the company had a string of product recalls involving both hip and shoulder replacement devices due to incorrect and transposed product labeling.

Now the company is facing issues with its Optetrak knee component. Produced for a number of years, the products that were manufactured 2011-2012 have been shown to fail due to a “finned” tibial tray that was only produced during these periods. Since 2011, the FDA has received reports of early device failure in such instances where these models have been implanted—speculating that the finned design does not allow for adequate adherence to the patient’s bone. Such failure could require 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


Shouldn’t You Have Years of Trouble-Free Enjoyment?

Most knee replacement surgeries give the recipients years of improved function with fewer problems and less pain—but not always. Sometimes product failure involves a defectively designed component that requires correction, usually at the inconvenience and suffering 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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