In February 2022, Exactech issued recalled about 140,000 knee replacements that were sold since 2004 because they can wear out early, crack or break, and require corrective revision surgery.
Need a Texas Exactech Knee Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a defective knee replacement or needed surgery, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: Exactech Recalls 140,000 Knee Replacements
In February 2022, Exactech issued a recall for about 140,000 knee and ankle replacements that were implanted in patients in the U.S. since 2004 because they can wear out early, crack, break, fail prematurely, and need corrective revision surgery.
The recall involves the Exactech Optetrak, Exactech Optetrak Logic, and Exactech Truliant knee implants. They contain a plastic insert that was packaged in a defective vacuum bag. The defective bag allowed the plastic component to be exposed to oxygen, which can cause it to wear out significantly faster than normal.
According to Exactech:
“[The problem] can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”
Symptoms of a Defective Knee Replacement
People who were implanted with a defective knee replacement may experience the following symptoms:
- Knee pain or swelling
- Painful walking
- Inability to put weight on the knee
- Abnormal sounds (grinding, clicking, etc.)
- Corrective surgery
List of Recalled Knee Replacements
In February 2022, Exactech issued a Class II recall for the following knee and ankle replacements:
- Exactech Optetrak knee implants (60,926 sold since 2004)
- Exactech Optetrak Logic knee implants (60,518 sold since 2009)
- Exactech Truliant knee implants (24,727 sold since 2017)
- Exactech Vantage ankle replacements (1,561 sold since 2016)
What is the Optetrak Tibial Tray?
Exactech Inc. of Gainsville, Florida manufactures the Optetrak® Tibial Tray, a metal component that is used in total knee replacement surgery (arthroplasty) in patients with severe arthritis or knee injuries.
Exactech Knee Implant Failure
Exactech knee replacements have been sold in the U.S. since 1994, but there were major design changes in 2011 and 2012. These new Optetrak knee replacements featured a “finned” tibial tray — and they have been linked to many reports of premature loosening and failure.
Problems With Finned Tibial Trays
The “finned” tibial tray on Exactech Optetrak knees may not bond adequately between the patient’s knee bones and the implant. This can cause loosening, instability, pain, and other problems. In most cases, early failure of a knee implant requires revision surgery. In 2013, Exactech switched from the “finned” tibial tray to a “fit” tibial tray.
Symptoms of Exactech Knee Failure
- Swelling from fluid build-up
- Unstable knees
- Trouble walking
- Bone fracture
- Muscle loss
Study Blames Design Flaws on Exactech Knee Problems
Knee implants fail for many reasons, but sometimes the problem is a defective part. Soon after Exacted created the Optetrak by making slight design changes to the Install® knee implant, using an approval loophole known as a the 510(k) system to avoid costly clinical trials.
In a study of 110 patients with the Exactech Optetrak knee, experts warned about “poor results” compared to the Exactech Install knee. The researchers observed the following problems within 2 years:
- 15% of patients were disappointed or dissatisfied
- 22% were painful and required regular painkillers
- 22% were “evolving toward tibial implant loosening”
- 21% had signs of patellofemoral conflict
- 12% of patients needed another surgery within 5 years due to tibial loosening, instability, or pain
The study was titled “Poor results of the Optetrak cemented stabilized knee prosthesis after a mean 25-month follow-up” and the conclusions were based on data from 110 patients.
Exactech Knee Lawsuit Settlement
In December 2010, Exactech agreed to a $3 million settlement with the U.S. Department of Justice to resolve investigations into illegal kickback payments to surgeons who performed hip and knee replacements.
Exactech Knee Recall
In July 2012, Exactech recalled the Optetrak Cemented Trapezoid Tibial Tray (Size 1F/1T, 2F/1T) and the Optetrak Rotating Bearing Knee Tibial Tray, Finned (Size 2F/1T) because they may be mislabeled.
Need an Exactech Knee Lawyer in Texas?
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