Exactech Optetrak Knee Implant Lawsuit
Problem summary
Patients who underwent knee replacement surgery to receive an Exactech Optetrak implant may face an increased risk of premature device failure and other serious complications possibly requiring painful revision surgery. According to reports, problems with the Optetrak knee device may prevent the implant components from properly adhering to the patient’s leg bones, which may result in implant loosening, pain, infection and instability occurring within just a few years of the replacement surgery. The main issue with Exactech Optetrak knee implants is believed to be associated with a previous finned tibial tray design that was not able to endure stress placed on the knee joint, a design the company quietly updated in a so-called “silent recall” in 2013. Unfortunately, some patients implanted with the older finned models have suffered premature failure of the device allegedly caused by problems with the implant’s defective design.
About Exactech Optetrak Knee Implants
Exactech is a global medical device manufacturer best known for its knee replacement systems, such as the Optetrak knee implant, a device designed to relieve pain and increase range of motion in patients with knee joints damaged due to severe arthritis or traumatic injury. Exactech has been producing its Optetrak knee replacement system in various forms for more than 20 years, but some versions of the implant manufactured in 2011 and 2012 have been associated with an unexpectedly high rate of premature failure requiring revision surgery to correct. These devices featured what is known as a “finned” tibial tray, which some believe may not allow for adequate adherence to the surgical cement typically used in knee replacement surgeries.
Since 2011, the FDA has received reports of adverse events involving the Exactech Optetrak knee implant, a device that was fast-tracked through the agency’s 510(k) approval process based on its similarity to other knee implants already on the market. The FDA’s 510(k) program is beneficial in that it expedites the approval process, bringing potentially life-changing medical devices to the market faster and making them readily available to consumers. However, because this process doesn’t require manufacturers to conduct rigorous testing on their products before submitting them for approval, many knee implants are approved based on the merits of defective devices that later end up being recalled from the market.
In September 2011, the FDA issued a Class 2 recall for the Exactech Optetrak Tibial Tray due to the potential for the tray to be mislabeled. The following year, a study published in Orthopaedics & Traumatology: Surgery & Research found that tibial loosening was occurring in patients implanted with the Exactech Optetrak knees just 25 months after the knee replacement surgery, and that the implant recipients were suffering serious complications like device wear and fragmentation as a result. In 2013, Exactech quietly changed the design of its Optetrak knee implant to feature a “fit” tibial tray, as opposed to a “finned” tibial tray, in hopes that the new device would achieve better long-term results than the 2011 and 2012 versions of the implant.
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Exactech Optetrak Knee Implant Injuries
- Reduced range of motion
- Fractures
- Joint infections
- Inflammation and swelling
- Persistent pain
- Mobility issues
- Muscle loss
- Implant loosening
- Fracture
- Disassociation of implant
- Change in component position
- Knee joint instability
- Patellofemoral conflict
- Need for revision surgery
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Exactech Optetrak Knee Implant Resources
Exactech Optetrak Knee Implant Settlements & Litigation
Hundreds of thousands of knee replacement procedures are performed in the United States every year, and that number is expected to quadruple over the next ten years, as more and more individuals require prosthetic knee implants due to arthritis, traumatic injury or excessive wear and tear on their knee joints. When performed correctly, with a safe and reliable device, this procedure can significantly improve the quality of life of individuals with damaged knee joints, offering decades of pain-free stability and improved mobility. However, when an artificial knee implant fails, the consequences can be devastating. Several lawsuits have already been filed against Exactech, alleging that Optetrak design defects caused the devices to fail prematurely, requiring risky revision surgery. According to allegations raised in Exactech Optetrak lawsuits, the device manufacturer knew or should have known that the knee replacement system was prone to premature failure and other complications, yet continued to market the medical device as a safe and effective knee replacement system.
If you or a loved one has suffered injuries allegedly caused by a defective knee implant, contact an experienced product liability lawyer today for legal help. An Exactech Optetrak lawsuit can help you recover damages for unexpected medical expenses, pain and suffering, lost wages, loss of future earning capacity, long-term medical care, permanent disability, and other complications due to revision surgery.
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