Overview of Exactech Recall
On February 7, 2022, Exactech issued a letter to patients and surgeons recalling over 147,000 of its knee and ankle replacement devices. These devices were surgically implanted from 2004 through 2022.
The letter from Exactech states that one component of the knee replacement, the tibial polyethylene insert, may have been compromised due to faulty vacuum bag packaging. The vacuum bag allowed the insert to be exposed to too much oxygen. Oxidation can damage these inserts or cause them to wear out more rapidly once they are implanted in the body.
What is a Tibial Polyethylene Insert?
The tibial polyethylene insert is a plastic component of the device that acts as the cartilage between the thigh bone (femoral piece) of the knee replacement and the shin bone (tibial) insert. In ankle replacements, the polyethylene layer fits between the shin bone (tibia) and the foot bone (talus).
What are the Warning Signs of a Defective Knee or Ankle Replacement Device?
Symptoms of an Exactech knee or ankle device failure would include:
- Pain in the knee or ankle replacement area
- Inability to bear weight on the knee or ankle
- Grinding noises
- Swelling in the knee or ankle
Patients experiencing these symptoms may have sustained bone loss or bone loosening. This will often require revision surgery, meaning additional unnecessary pain, rehabilitation, and medical expenses. These patients may be entitled to financial compensation for defective Exactech devices.
What Devices Were Recalled?
The Food and Drug Administration (FDA) classifies this recall as a Class 2 recall. This means that the product can cause temporary or medically reversible adverse health consequences. The specific devices include the Optetrak®, the Optetrak Logic®, the Truliant ®, and the Vantage®; however, it is not necessary for you to know the specifics of your device as it will be available in your medical records.
Who Should I Contact if I Believe I’ve Been Injured by a Faulty Knee or Ankle Replacement?
If you feel you have been injured as the result of an Exactech knee or ankle device failure, do not hesitate to reach out to our firm. An attorney can set up a free consultation and help you identify if your injury is related to one of these faulty devices, and if so, work to compensate you for your damages. Brett H. Oppenheimer is a lawyer who has years of experience in holding medical device companies accountable for their defective products.