Exactech OPTETRAK® Knee and Ankle Insert Lawsuits

An OPTETRAK lawsuit is a legal claim for financial compensation by plaintiffs who need revision surgery due to their recalled Exactech knee or ankle implant device. In this article, our mass torts defense attorneys discuss:

• 1. Which knee and ankle inserts have been recalled?
• 2. Why are they being recalled?
• 3. What are the symptoms of a failing Exactech insert?
• 4. Will I need a revision surgery?
• 5. What is the current state of the litigation?
• 6. How much money can I get?
• 7. What should I do if my insert was recalled?

1. Which knee and ankle inserts have been recalled?

The medical device manufacturer Exactech has recalled the following knee and ankle polyethylene inserts that were manufactured from January of 2004 to January of 2022.

System	Recalled Device
OPTETRAK®	All–polyethylene CR All–polyethylene PS Tibial Components CR Tibial Inserts CR Slope Tibial Inserts PS Tibial Inserts HI–FLEX® PS Tibial Inserts
OPTETRAK  Logic®	CR Tibial Inserts CR Slope Tibial Inserts CRC Tibial Inserts PS Tibial Inserts PSC Tibial Inserts CC Tibial Inserts CR Tibial Inserts
TRULIANT®	CR Slope Tibial Inserts CRC Tibial Inserts PS Tibial Inserts PSC Tibial Inserts
VANTAGE®	Fixed-Bearing Liner Component

This recall began on August 31, 2022, and was expanded on February 7, 2022, to include all knee and ankle arthroplasty polyethylene inserts packed in non-conforming bags despite their label or shelf life. A total of 147,732 inserts are being recalled.¹

2. Why are they being recalled?

The recalled Exactech inserts were manufactured in vacuum bags that lacked an ethylene vinyl alcohol (EVOH) barrier layer to augment oxygen resistance. This increased oxygen diffusion can degrade the inserts’ UHMWPE (ultra-high molecular weight polyethylene) material. As a result, patients with these recalled inserts may experience:

• accelerated wear debris production,
• bone loss, and/or
• cracking of the insert

In short, increased oxidation of the inserts’ mechanical properties may result in the patient requiring a corrective revision surgery.

This recall of Exactech’s knee and ankle arthroplasty polyethylene inserts has been classified as a class II recall by the FDA. This means that patients implanted with these inserts may experience temporary or medically reversible health consequences.²

3. What are the symptoms of a failing Exactech insert?

Potential signs that a recalled Exactech insert is degrading are:

• pain
• grinding noises
• loss of ability to bear weight
• knee or ankle instability
• swelling

Anyone implanted with a recalled Exactech insert and who is experiencing symptoms is advised to consult with their doctor.³

4. Will I need revision surgery?

Some patients implanted with a recalled Exactech knee or ankle insert may need a corrective revision surgery.

Note that asymptomatic patients are not advised to get surgery preemptively. Instead, their doctors can monitor their inserts through periodic X-rays. And there may be other treatment options available other than additional surgeries.⁴

5. What is the current state of the litigation?

Litigation against Exactech is just beginning. Implant victims are expected to sue for:

• defective design,
• failure to warn, and
• negligence.

It is likely that all the plaintiffs’ lawsuits will be consolidated into a multi-district litigation (MDL), which helps to streamline the litigation process. Eventually a few bellwether trials will go forward. And the result of these verdicts will then set the stage for negotiations with the remaining MDL plaintiffs.

6. How much money can I get?

Victims of the recalled Exactech knee or ankle inserts may be able to recover compensatory damages for:

• medical bills, especially for the revision surgery and rehabilitation;
• lost wages from being unable to work during the recovery time; and
• pain and suffering.

7. What should I do if my insert was recalled?

First contact your physician to discuss your options. Then call Shouse Law Group to discuss filing a lawsuit against Exactech in pursuit of the largest settlement possible under the law.

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