Soon after Exactech changed the Optetrak® knee implant in 2011 and 2012, patients began suffering early knee implant failure due to poor bonding between their bones and the implant.
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 bad knee replacement or needed surgery, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
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.
What is the problem?
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?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Exactech knee lawyers for a free lawsuit review.