Published by Knee replacement patients who received the Exactech Optetrak implant have reported suffering adverse health complications, including failure of the device due to tibial insert wear.
Free Confidential Lawsuit Evaluation: If you or a loved one had problems following knee replacement surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Table Of Contents
- Update: Exactech Knee Replacement Lawsuit Filed Over Knee Implant Failure
- What’s the Problem?
- Exactech Optetrak Knee Recall
- Exactech Knee Replacement Complications
- Total Knee Replacement Surgery
- Symptoms of Knee Replacement Failure
- Knee Replacement Alternatives
- Update: Exactech Knee Replacement Recall Over Premature Failure Risk
- Pennsylvania Woman Alleges Complications from Exactech Knee Replacements
- Georgia Plaintiff Claims ‘Severe and Permanent Injuries’ from Exactech
- Exactech Knee Lawsuit Settlement Information
- FAQs:
- Get a Free Exactech Optetrak Knee Implant Lawsuit Evaluation With Our Lawyers
Update: Exactech Knee Replacement Lawsuit Filed Over Knee Implant Failure
A product liability lawsuit recently filed in Tennessee alleges that packaging problems caused the premature failure of an Exactech Truliant after a polyethylene insert degraded, resulting in the need for revision surgeries only a few years after the device was implanted. [1]
The lawsuit was filed on behalf of Plaintiff Billy Hursey, who claims he received an Exactech Truliant Posterior Stabilized Knee System in July 2021 during a joint replacement surgery.
After suffering from pain, instability, synovitis, and swelling, which ultimately resulted in his inability to walk, Hursey had the implant removed during revision surgery in August 2022.
During the operation, the surgeon noted that the tibial insert was damaged along the medial edge, which the lawsuit claims was a direct result of the packaging defects.
As a result of Defendants’ failure to properly package the Truliant Device prior to distribution, the polyethylene liner prematurely degraded and Plaintiff Billy Hursey required revision surgery due to severe pain, swelling, and instability in the knee and leg, the complaint states. These injuries were caused by early and preventable wear of the polyethylene insert and resulting component loosening and/or other failures causing serious complications including tissue damage, osteolysis, permanent bone loss and other injuries. Stated Hursey.
Related Article: Knee Replacement Revision Surgery
What’s the Problem?
Exactech has manufactured prosthetic knee replacements for over 30 years, and the Optetrak line of knee and ankle implants has been sold on the U.S. market since 1994. However, medical devices produced in 2011 and 2012 were different in that they featured a “finned” tibial tray, which some believe may not properly bond with surgical cement.
Optetrak knee implants that were manufactured with finned tibial trays have been reported to fail prematurely (in many cases in as little as 1-2 years after surgery) and may cause other adverse health consequences.
Exactech Optetrak Knee Recall
According to the Food & Drug Administration (FDA), in July 2012, the U.S. agency announced a nationwide recall for the Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T, and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled [2].
Exactech Knee Replacement Complications
- Severe pain
- Inflammation
- Infection
- Bone damage
- Muscle damage
- Loss of / lack of bonding of the knee implants to the bone
- Tibial loosening
- Disassociation of the insert
- Change in the position of the components
- Patello-Femoral Tracking-Lateral Release
- Exactech implant failure
- The need for knee replacement revision surgery
Total Knee Replacement Surgery
Total knee replacement (TKR), also known as arthroplasty, involves resurfacing the damaged bone and cartilage of the knee joint. During this procedure, the joint is exposed by an incision made down the center of the knee.
The damaged portion of the femur, tibia, and patella is then removed and replaced with metal and/or plastic components that are intended to replicate the knee’s natural movement and function.
Symptoms of Knee Replacement Failure
- Knee pain
- Reduced range of motion
- Swelling
- Loss of mobility
- Instability or trouble balancing
Knee Replacement Alternatives
Total knee replacement with medical devices like the Exactech Optetrak implant should only be considered when all other options have failed. Many patients can benefit from alternative treatments, which include:
- Weight loss and exercise – Losing just a few pounds can take a huge amount of strain off the knee throughout daily activities.
- Physical therapy – Can help reduce pain associated with a knee injury and help improve mobility.
- Knee injections (hyaluronic acid) – Lubricates the knee joint and improves shock absorption, which helps reduce pain and improve knee mobility.
- Acupuncture – Ancient Chinese method that uses sharp, thin needles to impact nerves and change the flow of energy within the body.
- Arthroscopic surgery – Far less invasive than total knee replacement, arthroscopy involves removing bone fragments and pieces of a torn meniscus while repairing ligaments and damaged cartilage.
Update: Exactech Knee Replacement Recall Over Premature Failure Risk
As claimed by Exac Tech, a sweeping recall of the agency knee and ankle replacement systems has been announced after it was discovered that they contained a defective plastic insert component that caused them to fail prematurely [3].
The insert systems have been around since 2004 and are used in approximately 140,000 knee and ankle replacement surgeries. The Exactech insert systems affected by the recall include:
| System | Release Date |
| OPTETRAK® | 1994 |
| OPTETRAK Logic® | 2009 |
| TRULIANT® | 2017 |
| VANTAGE® | 2016 |
Exactech issued the knee and ankle replacements recall after discovering that the polyethylene insert components of all systems made after 2004 were packaged in defective vacuum-seal bags. The defective packing caused the oxidation of the polyethylene insert material. This defect will be the core of any Exactech knee replacement lawsuit.
Pennsylvania Woman Alleges Complications from Exactech Knee Replacements
January 19, 2018 – A woman from West Mifflin, Pennsylvania, claims in a new products liability lawsuit that she was injured by a defective Exactech Optetrak Knee replacement device.
The suit was filed by Plaintiff Diane Stanesic, who alleges that she underwent a total knee arthroplasty with defective Exactech Optetrak knee implants. As a result of problems with the device, Stanesic needed revision surgery to remove the Exactech implant, according to the lawsuit.
Georgia Plaintiff Claims ‘Severe and Permanent Injuries’ from Exactech
October 2, 2017 – A patient who underwent surgery with the Exactech knee replacement system has filed a lawsuit against the manufacturer, alleging that the “device caused him severe and permanent injuries,” as well as the need for rehabilitation and ongoing medical care.
Related Article: Exactech Knee Class Action Lawsuit
Exactech Knee Lawsuit Settlement Information
Our lawyers estimate that the settlement value for successful Exactech lawsuits is between $100,000-$225,000. These estimates are based on the average compensation payouts in other tort cases involving severe knee injuries from Exactech knee replacement systems.
We have recently come to believe that these cases are stronger than we initially thought, and we are hopeful that Exactech has the funds to pay out a global settlement without filing for bankruptcy. This is also because we are seeing fewer Exactech lawsuits than our lawyers predicted, and fewer lawsuits equal more money for victims who file lawsuits against the company.
Related Articles:
See all related medical device lawsuits our attorneys have taken on.
FAQs:
What Is the Lawsuit Against Exactech Knee Replacement?
The lawsuit against Exactech knee replacements is centered on over 1,100 patients who have sued the company due to defects in the packaging of its joint replacement devices. The faulty packaging led to exposure of plastic components to excessive oxygen, which could cause significant complications after implantation.
Is There a Recall on Exactech Total Knee Replacement?
There is a recall of Exactech total knee replacements because approximately 80% of knee and ankle replacement devices manufactured since 2004 were packaged in defective bags. This faulty packaging can lead to oxidation over time, increasing the risk of complications.
What Problems Are Associated With the Exactech Knee Replacements?
The problems that are associated with the Exactech knee replacements is that they were packaged in defective bags, which can cause oxidation of plastic components. This can lead to implant failure, pain, and the need for revision surgery.
Get a Free Exactech Optetrak Knee Implant Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Exactech Knee Lawsuits. We are handling individual litigation nationwide and currently accepting new Exactech implant cases in all 50 states.
Free Case Evaluation: Again, if you were forced to undergo revision surgery or suffered complications after knee surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
References:
- https://www.schmidtandclark.com/wp-content/uploads/2022-12-14-Complaint.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109613
- https://www.exac.com/medical-professionals/recall-information/
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