While millions of Americans have undergone knee replacement surgeries to correct injuries, manage symptoms of arthritis or increase mobility, knee replacement system Exactech Optetrak has been linked to damaging complications. Here, the medical device and product liability attorneys at The Law Offices of Peter Angelos discuss Optetrak knee replacement complications and how a dedicated product liability attorney can help you receive compensation for your pain and suffering.
Exactech Optetrak Knee Replacement Implants were Fast-Tracked by the FDA
The Optetrak knee replacement system was introduced in 1995 and is made up of several materials such as polyethylene and chromium-cobalt alloy. The two-part knee replacement system is an implant that replaces the patient’s former joint. Through a 510(k) process, the Exactech Optetrak knee replacement system was fast-tracked through the FDA approval process in order to be available to patients in need of knee replacement surgery. While this allowed the knee replacement system to be promptly introduced to patients in need, it also means it is likely that the system did not undergo sufficient testing and evaluation before it was approved for use.
Exactech Optetrak Tibial Tray Was Recalled in 2011
In 2011, the Optetrak tibial tray underwent a Class 2 recall by the FDA after claims of significant complications arose surrounding the knee replacement implant. Complications that were reported included, but were not limited to, intense pain, infection and mobility issues that often required additional surgery to correct. Optetrak knee replacements have also been linked to excessive wear on the implant piece, which can cause intense pain and even fractures in the implant that can release fragments into the body. In a study published by Orthopaedics and Traumatology: Surgery & Research, approximately 22% of 106 patients that participated in the study claimed they had regular pain that required painkillers on a consistent basis. In addition, 22% of patients claimed they suffered from early stages of tibial loosening.
Exactech Optetrak Knee Replacement Implants are Linked to a Variety of Symptoms
If you have undergone an Optetrak knee replacement surgery to treat arthritis, mobility issues or another health condition, you may be at risk for experiencing painful and damaging complications as a result of the procedure. It is important to immediately contact your health care professional if you notice any signs and symptoms including:
- swelling and inflammation,
- mobility, movement or stability issues,
- bone fractures or fragmentation, or
- implant loosening or shifting.
Speak to an Experienced Product Liability Attorney at The Law Offices of Peter Angelos
It is a stressful, painful and emotional experience when a necessary knee replacement results in severe complications that may require additional surgeries to repair. This can lead to significant medical expenses in addition to the pain and suffering you are already experiencing as a result of unexpected side effects. When a medical device is fast-tracked by the FDA for patient use, there is an increased risk of complications as the product most likely does not undergo sufficient medical testing, and this may have been the case for the Exactech Optetrak knee replacement implant. If you or a loved one underwent an Optetrak knee replacement surgery and experienced complications such as pain, infection, mobility issues, additional surgery or more, consult the team of attorneys at The Law Offices of Peter Angelos today.