In recent years, the U.S. Food and Drug Administration (FDA) has added numerous reports of early failure of the Exactech Optetrak knee replacement system to its Manufacturer and User Facility Device Experience (MAUDE) database.
Now, several patients have filed lawsuits against Exactech, alleging that premature failure of their Exactech Optetrak knee replacement implants caused severe and permanent personal injuries. As of November 2017, Exactech faces lawsuits over its Optetrak knee replacement system in federal courts in both Georgia and Alabama.
Patients who filed lawsuits against the company claim that, after receiving the Optetrak knee replacement implants, they experienced severe pain, instability, and other complications that required them to undergo excruciating revision or reconstructive surgery.
As a result, the plaintiffs in these cases are seeking a wide range of economic, non-economic, and punitive damages, as well as attorneys' fees and costs.
If you or a loved one suffered complications caused by defective Exactech Optetrak knee replacement implants, you may be entitled to compensation. Here's what you should know.
About the Exactech Optetrak Knee Replacement System
Made by Exactech—a leading developer, manufacturer, marketer, and distributor of orthopedic implant devices and related surgical instrumentation—the Optetrak knee replacement system was approved by the U.S. Food and Drug Administration in 1994.
The total knee replacement system gained FDA approval under the agency's much-scrutinized 510(k) process, which grants fast-tracked approval to devices that are substantially similar to existing implants, rather than requiring manufacturers to prove a device's safety and efficacy through exhaustive tests and clinical trials.
According to Exactech prescribing information, the Optetrak knee replacement system is indicated for use in adult patients who require total knee replacement as a result of post-traumatic degenerative problems or conditions such as osteoarthritis, rheumatoid arthritis, and osteonecrosis. The Optetrak knee replacement system can also be used in revision or reconstructive surgeries after other knee replacement implants have failed, provided that the patient has sufficient bone stock and soft tissue integrity.
Complications Associated With Exactech Optetrak Knee Replacement Implants
For patients who report problems with their Exactech Optetrak knee implants, loosening of the device's tibial component is a common complaint. This loosening can cause excessive device wear and tear, fragmentation, and complications such as:
- Severe pain
- Joint instability
- Bone fractures
- Reduced mobility
- Limited range of motion
- Loosening and dislocation of the device itself
- Total implant failure
Often, the only way for patients to relieve the above symptoms is to undergo invasive and painful revision or reconstructive surgery. These corrective surgeries are considered even more risky than an initial knee replacement procedure, as the process of removing a faulty implant may itself cause damage that necessitates bone reconstruction. Patients who have knee revision or reconstructive surgery due to a failed implant can experience significant pain and suffering.
Exactech Optetrak Tibial Tray Recall
The Optetrak knee replacement system has been on the market since 1994, but in 2008, the company began receiving reports of early failure of the device's tibial tray. As a result, Exactech replaced the problematic components with newly-designed finned tibial trays known as “fit trays.”
Unfortunately, the redesigned tibial trays don't appear to have solved Optetrak knee replacement system's early failure problem. The finned tibial trays were prone to excessive wear and tear, and didn't allow for adequate adherence.
The Optetrak tibial tray was the subject of an FDA Class 2 Device Recall, which Exactech initiated in September 2011. According to the FDA, a Class 2 recall designation indicates that use of the device in question “may cause temporary or medically-reversible adverse health consequences.”
Did Your Exactech Optetrak Knee Replacement Implants Fail Prematurely?
If your Exactech Optetrak knee replacement implants failed prematurely, resulting in significant pain, and necessitating revision or reconstructive surgeries, it's important to understand your legal rights.
McGartland Law Firm's award-winning defective medical device attorneys can help you explore your options. Contact McGartland Law Firm today to schedule an appointment for a free initial review of your knee replacement failure case.