Exactech Knee Recall Issued for Optetrak, Optetrak Logic and Truliant Implants That May Fail

A massive recall has been issued for more than 140,000 Exactech knee replacement systems implanted in the United States since 2004, as well as hundreds of Exactech ankle replacements, which contained a defectively packaged polyethylene insert that may cause implants to fail prematurely, resulting in the need for additional surgery.

Exactech is a global medical device manufacturer founded in 1985, which now acknowledges that it has been distributing defective and potentially dangerous knee and ankle replacement systems for almost two decades, including Exactech Optetrak, Optetrak Logic, Truliant and Vantage implants.

The Exactech Optetrak knee replacement system was introduced in the United States in 1994. However, units sold since 2004 may have contained “out-of-specification” vacuum bags for a plastic polyethylene insert used between the knee components. This defective packaging allows oxygen to reach the plastic inserts before they are implanted, causing the component to oxidize and wear out much earlier than expected, or become damaged after it is inside in the body.

As a result of the Exactech knee problems, patients may experience severe knee pain, swelling or instability, as well as pain while walking or an inability to bear weight. Other symptoms of an Exactech knee failure may include knee grinding, clicking or other noises, often resulting in the need for knee revision surgery or procedures to replace the polyethylene insert.

According to an Exactech recall notice (PDF) sent to surgeons on February 7, accelerated polyethylene wear caused by the packaging problems appears to be resulting in a “statistically significant” higher overall rate of Exactech knee revision surgeries required after the components fail, compared to available data on other competing total knee replacement systems.

The recall impacts 60,926 Exactech Optetrak knee implants sold since 2004, as well as 60,518 Exactech Optetrak Logic knee implants sold since 2009 and 24,727 Exactech Truliant knee implants sold since 2017. The same defective polytehylene inserts were used in 1,561 Exactech Vantage ankle replacement systems sold since 2016, which have also been recalled.

Exactech Knee Problems Reported For Years Before Recall

While Exactech knee failures have been reported for years, and the company has faced a number of Exactech Optetrak lawsuits filed over alleged design defects, the manufacturer now indicates that excessive oxygen diffusion may result in oxidization of the plastic parts, which can lead to severe degradation, cracking and fractures over time. The end result of the knee complications typically cause an early knee revision or replacement surgery well before the expected time for a joint replacement.

Data submitted to national joint registries maintained in Australia, United Kingdom and New Zealand have confirmed that the Exactech Optetrak knee failure rates are substantially higher than what is seen with other total knee replacement systems. The overall rate of knee replacement failures with Exactech Optetrak were two-times higher. However, when looking at rates of knee replacement and revision surgery involving complications consistent with a polyethylene liner failure, such as loosening, lysis and pain, the manufacturer indicates that there is a three to- seven fold failure rate.

“We are uncertain if the root cause of these Optetrak higher and earlier than expected revision rates are due only to the non-conforming vacuum bags,” Exactech states in the recall notice. “The uncertainty in assessing the root cause stems from the fact that the registry data of Optetrak Knee System report outcomes for polyethylene components in both conforming and non-conforming packaging, and the registries do not contain packaging information.

Exactech Optetrak Recalls Initiated in August 2021 Now Expanded

Exactech first began recalling knee replacement products in August 2021, but at the time limited the actions to only those products with a remaining shelf life of five years or greater after August 31, 2022. However, it now acknowledges that knee implants distributed between August 2021 and January 2022 also had non-conforming bags for the polyethylene inserts, which may cause premature failure.

All Exactech Optetrak, Optetrak Logic and Truliant knee implants sold since 2004 are now impacted, regardless of label or shelf-life. The company estimates that the total recall affects 147,732 devices, leaving individuals throughout the United States at a potentially increased risk of premature knee failure, and requiring additional medical expenses.

Exactech Optetrak Knee Lawsuits

Over the past few years, a number of Exactech Optetrak knee lawsuits have been filed by individuals who experienced premature failure, pointing out that the implants had an abysmal failure rate.

As early as 2017, lawsuits over Exactech knee implants indicated that an alarming rate of adverse event reports were being submitted to the FDA, which resulted in what some said was a “silent” Exactech knee recall when the company began slowly and quietly replacing the tibial trays of some Optetrak models.

The Exactech Optetrak knee replacement system was introduced through the FDA’s controversial 510(k) fast-track approval process, meaning that the manufacturer did not have to undergo extensive testing for safety and effectiveness, but only needed to show that the device was “substantially equivalent” to existing devices.

This latest recall notice now suggests that manufacturing changes in about 2004 caused knee replacements to be shipped with “non-conforming” vacuum bags that failed to protect the polyethylene inserts.

While Exactech has indicated that it intends to cover all recall-related “out-of-pocket” expenses incurred by patients, limited information has been provided about what rights claimants may give up by seeking this limited reimbursement, when the true value of any knee replacement settlements through a personal injury lawsuit would be substantially higher.