Exactech Knee Replacement failures are leading to a growing number of lawsuits from patients who have been injured because of the product. The U.S. Food and Drug Administration has been receiving adverse event reports regarding the Optetrak model since 2011.

A retrospective study published in Science Direct the following year found that 22 percent of patients who received an Exactech Optetrak knee replacement experienced pain severe enough to require pain relieving medications. Out of 106 patients, thirteen were forced to undergo revision surgery within 5 years (the normal lifespan of a knee prosthesis is 15 to 20 years or more).

Many of these failures have been linked to a specific component, known as the tibial tray. This is the part that is attached to the patella (shinbone), serving to support the upper assembly. The Optetrak tibial tray has been prone to failure has was subject to a Class 2 recall by the FDA.

About Exactech and the Optetrak Knee Replacement

Exactech began operations in 1994. Today, it is one of the dominant players in the global medical device market, specializing in knee prostheses.

The Optetrak was one of a number of Exactech knee replacement products that have been introduced over the past 25 years. This particular model was approved in 2007 through a controversial FDA process known as 510(k) Premarket notification.

Because the company was able to demonstrate that the Optetrak was “substantially equivalent” to a number of “predicate” devices already on the market, Exactech was excused from performing the stringent clinical studies that are normally required for device approval. A total of seven previously approved prostheses were listed on the application.

A Crucial Difference From Previous Exactech Knee Replacement Systems

Unlike the earlier knee replacements, the Optetrak tibial tray had a “finned” design. This may be the apparent cause of the premature failures. It is believed that the finned surface prevented the surgical cement used to fix the tibial tray in place from forming an adequate bond.

In 2013, Exactech came out with a newer design that promotes better adhesion. Many who wound up with the finned model have either experienced knee replacement failure or are at risk for complications in the future.

Signs of Knee Replacement Failure

An Exactech Knee prosthesis may be failing if the patient experiences any or all of the following symptoms:

• mild to severe joint pain
• decreased mobility and range of motion
• swelling due to inflammation or excess fluid
• Redness and abnormal warmth around the knee joint
• instability (the sensation that the knee will give out when weight is put on it)
• fever and muscle soreness
• skin rash (indicative of metal toxicity)

In addition to these external, readily observed symptoms, there may be other signs that are detectable only through a medical examination.

These include destruction of bone tissue due to fracturing or infection and a condition known as crystalline arthropathy, a type of arthritis characterized by an accumulation of sodium and/or calcium crystals around the joint.

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