Exactech Knee Replacement Failure

Santa Cruz, CA: Complaints regarding the design of the Exactech Optetrak knee replacement are coming to light, particularly allegations of early implant failures due to defective design.

A product liability lawsuit has been filed and more may result from the alleged design defect, as people who undergo joint replacement surgery with the Optetrak knee replacement experience early failure just a few years later. The problems with the Exactech Optetrack knee replacement system appear to be related to the use of a finned tibial trays.Failing knee replacements can result in the need for risky revision surgery.

Allegations in the lawsuit include claims that Exactech, Inc. knew or should have known that it’s knee implants were failing at an unreasonable rate, and should have warned patients and/ or the medical community yet failed to so.

“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,” the lawsuit states. “Reports in the Manufacturer and User Facility Device Experience (MAUDE) indicate instances of revision due to ‘loose tibial component’, ‘aseptic loosening’, ‘pain and visible loosening’, and ‘pain, limited mobility, knee swelling and sensitivity’ due to ‘loose’ joint. These early onset failure mode reports are representative of the increased rate of incidents of which Defendants had become internally aware.”

Originally approved for use by the FDA in 1994, the Optetrak knee replacement system has had several revisions, all approved through the FDA’s 510(k) process, which does not require extensive testing of the system for safety and effectiveness. Rather, the company need only show that the revisions are “substantially equivalent” to existing devices.
 

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Last updated on Dec-6-23