Every year, approximately 700,000 Americans undergo knee replacement surgery.  Recent studies and adverse event reporting indicate that a popular replacement device, the Exactech Optetrak (“Optetrak”), is associated with early failure due to debonding of the tibial tray and catastrophic polyethylene wear.

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Dating back to 2008, Exactech learned that some patients were experiencing early failure of the Optetrak knee implant requiring revision surgery.  Rather than recall the device from the market, Exactech quietly redesigned the Optetrak knee implant in an effort to correct the problems but failed to warn orthopedic surgeons about this serious health risk.

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The Exactech Optetrak Knee System

The Optetrak knee replacement system is manufactured by Exactech, Inc.  The device was first cleared for marketing via the FDA’s “fast-track” 510(k) process in 1994.

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Under the 510(k) process, a manufacturer is not required to conduct clinical trials of the medical device it intends to market.  Instead, the company must only demonstrate that the new medical device is substantially similar to an older model before it can be sold and implanted into patients.

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Exactech Optetrak Knee Implant Failure

The Optetrak knee implant's failure has been attributed, in part, to a finned tibial tray which may not sufficiently bond to surgical cement and, therefore, cannot withstand the stress placed on the joint during normal use.  This “debonding” of the tibial tray causes the component to loosen can require a revision surgery.

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Exactech had become aware of the high early failure rate with the Optetrak knee implant as far back as April 2008.  By 2011, the FDA was receiving complaints about the Optetrak knee implant failing early.  Around this time, Exactech started to design a new tibial tray hoping it would correct the problem.

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In 2012, Exactech realized that the rate of finned tibial tray failure with the Optetrak knee implant was increasing.  In 2013, Exactech changed the design of the Optetrak knee implant to a “fit” tibial tray, which may achieve better long-term results than the prior finned tibial tray.  At this same time, rather than formally recalling the device, Exactech began replacing the finned tibial trays with the new design without alerting physicians about the real reason for the change.

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Adverse event reporting demonstrates that the Optetrak knee implant experiences polyethylene wear that causes early failure due of the device. Polyethylene wear refers to the plastic liner placed between the femoral and tibial components wearing away due to the compression forces from routne use. Often the polyethylene insert has been found to be completely disintegrated within a few years of implantation.

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Optetrak Knee Implant Injuries

When a knee implant fails, significant complications can occur. Some of these complications can take place years after the initial surgery. The Opetrak knee implant has been linked to serious injuries including:

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• Fractures

• Gait impairment

• Infection

• Loss of mobility and range of motion

• Pain

• Revision surgery

• Swelling and inflammation

Exactech Optetrak Knee Implant Litigation

In 2017, law suits began to be filed against Exactech because of the Optetrak knee implant's failures.

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Plaintiffs have so far alleged that the Optetrak knee implant is defectively designed because of its propensity to loosen requiring the need for revision surgery.  Plaintiffs also have alleged that Exactech failed to adequately warn orthopedic surgeon and patients about this risk.  In addition, Plaintiffs have alleged that Exactech did not properly test the Optetrak knee implant prior to placing it on the market.

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Contact Us

If you or someone you love has suffered injury from an Exactech Optetrak knee implant or another artificial knee device, you may be entitled to significant compensation for your injuries.

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To speak with an experienced, knee implant lawyer, contact Weintraub Law at (504) 656-6280 , or complete the Case Evaluation Form on this website for a free, confidential, case assessment.