Exactech Knee Recall
The number of knee replacement surgeries has exploded since the first procedure over 40 years ago. Now, around 700,000 Americans annually submit to knee replacement procedures. And that number will likely quadruple over the next 10 years. Knee replacements are usually performed on patients – most of them over 50 – with knees damaged from arthritis, traumatic injuries or just plain wear and tear from working for a long time.
When they receive a safe, reliable device, knee replacement patients typically recover 15 to 20 years of future pain-free mobility. However, if the replacement device fails, a variety of complications can occur, arising anywhere from shortly after the procedure to months or years later.
Since its FDA approval in 1994, the Exactech Optetrak knee replacement system has undergone several revisions, all approved through the FDA’s 510 (k) “fast track” program. But in 2017 a product liability lawsuit was filed by a patient in Georgia. He alleges there is a design defect in one of the company’s revisions of what was previously a very stable and reliable apparatus. Now, other allegations of similar failures in units from that same redesigned lot are coming to light. The problem with this version of the Optetrak device appears to be connected to the use of a finned tibial tray component which leads to operational failure and necessitates the need for risky revision surgery.
Allegations in this lawsuit also include claims that Exactech, Inc. – the device manufacturer – “knew or should have known that its knee implants were failing at an unreasonable rate, and should have warned patients and/or the medical community yet failed to so.”
A Well-Worn Path to Another Medical Device Failure
The Optetrak knee replacement is just one of many devices which were accelerated through the FDA 510(k) program. Medical device manufacturers use (many say abuse) this premarket program which allows them to bring a device to market with limited testing, if there is already a similar product on the market. Yet it turns out that over the years many faulty replacement knees and other defective surgical devices have been fast-tracked through 510(k), with outcomes that were not altogether positive.
Though 510(k) can benefit patients when reputable medical devices are brought to market faster than usual, premature release of less tested medical technology brings unnecessary pain and other forms of needless suffering to surgical patients who must undergo additional replacement surgeries.
Many knee replacement devices approved through 510(k) are failing in alarming numbers and exposing an institutional flaw in the FDA’s medical device approval process. These manufacturers deserve a large helping of blame for abusing what was meant to be a process to speed healthy recoveries. Some critics go even further, claiming such manufacturers view 510(k) as a way to dump substandard devices on an unsuspecting public.
FDA Recalls of Modified Optetrak Devices
Exactech has been successfully producing durable and safe knee replacement implants since the early 1980’s. But beginning in 2011, the functionality in its latest Optetrak knee replacement versions differed from those of previous models. The new version featured a “finned” tibial tray, which doesn’t uniformly adhere to surgical cement used in fusing such devices to existing bone and tissue. In September 2011, a Class 2 recall was issued for the Optetrak knee replacement implant. Two years later, Exactech changed their Optetrak knee replacement, discarding the finned tibial tray for a more stable design, essentially admitting to the 2011 version’s defects. So far, results from its new “fitted” tray appear quite positive. But the tens of thousands of patients who have the 2011 version may be at risk for future problems with their replacement knees.
Common symptoms of a failed Exactech knee implant include:
- Knee pain
- Reduced range of motion
- Loss of mobility
- Instability, trouble keeping your balance
If you or a loved one underwent revision surgery after an Exactech Optetrak knee replacement (or any defective knee replacement device) in 2011 or later, or if you are scheduled for one, contact Terry Bryant Accident & Injury Law now. With more than 30 years of experience fighting for injury victims, you can trust our seasoned lawyers to help. We’re available 24/7 to help protect your rights. You’re encouraged to call toll-free 1 (800) 444-5000 or to use our contact form to arrange a free consultation and learn about your legal options.