The FDA has recently received reports indicating problems with the Exactech Optetrak tibial tray. Patients complain of early device failure. Exactech Optetrak tibial tray failure reportedly stems from the tibial insert wear and tear, with the FDA receiving injury reports since 2011.

In September 2011, a Class II recall was issued for the Optetrak knee replacement. Exactech has been manufacturing knee replacement systems for over 30 years, and featured their Optetrak model.

In contrast to other models, the Exactech Optetrak was unique in its design because it did not require the need for cement. However, previous Exactech Optetrak tibial tray components had a “finned” design, which reportedly did not bode well for long term use and stress from daily activities.

Additionally, Exactech Optetrak was approved through the FDA’s 510(k) review, which means it quickly entered the market and was not required to pass any preclinical trials. As long as a product proves to work at an at least an equivalent level as a similar device, the product can qualify for the FDA’s program.

However, it has been alleged that Exactech did not thoroughly test the tibial tray components before releasing them in knee replacement systems, allegedly putting patients at unnecessary risk.

It has been further alleged that the company did not sufficiently examine the durability of the Exactech Optetrak tibial tray components, nor did they provide sufficient follow up studies or post market reviews.

Overview of Exactech Optetrak Tibial Tray Problems

The Optetrak tibial tray has been allegedly been unable to endure stress and movements from daily activities like walking, or any other activities involving bending the joints. By 2012, Exactech reportedly noticed the failure reports of this device component had been increasingly significantly in a short time span and worked to resolve the problem.

In reports later submitted in 2013 and 2014, Exactech allegedly conducted a “silent recall” campaign to replace all the relevant Exactech Optetrak tibial tray components. This was done in 2013, when Exactech updated the component to a “fit” tibial tray from a “finned” design, which was supposed to be longer lasting from the previous design.

According to the injury reports submitted to the Manufacturer and User Facility Device Experience (MAUDE), many patients needed revision surgery due to their Exactech knee replacements failing.

The FDA received injury reports since 2011, indicating the device failed and required patients to undergo risky and painful revision surgery. Common symptoms of Exactech Optetrak knee replacement failure include, but are not limited to:

• Infections and Inflammation of Implant Area
• Fractures
• Loss of Mobility
• Limited Motion
• Disassociation of Knee Replacement System
• Change in Component Position
• Instability

Patients who experience these problems will most likely have to undergo revision surgery, to remove and replace the knee replacement system. Often patients are at higher risk for infection from revision surgery, and will most likely take months to fully recover.

Even though knee replacement complications can be devastating to patients, some patients say Exactech allegedly failed to warn them against these problems.

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If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.

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