What is the Exactech Ankle Device that has been Recalled?

Although knee and hip replacement surgeries are common, ankle replacement surgery is another beneficial surgery for patients with joint conditions. Although it is not as common, it can help patients with maintaining their mobility. Ankle replacement surgery can also be painful for some patients, especially if another revision surgery has to be performed due to a defective medical device. This February, many patients may find themselves contemplating revision surgery after the recent recall by Exactech.

What was the most recent Exactech medical device recall?

This February, Exactech issued a voluntary recall of one of its most popular ankle replacement devices. This device was manufactured from 2017 to 2022. Per the company’s own statement, it was discovered that the packaging layers around the plastic insert had been “out of specification.”

The insert was exposed to oxygen. When the plastic insert is exposed to a certain amount of oxygen before it is implanted into a patient’s body, oxidation can happen. Oxidation causes the plastic insert to wear down earlier than predicted and lead to early device failure within the patient’s body.

What are the three parts of an ankle replacement device?

An ankle replacement device contains three parts: the tibial component, polyethylene, and the talar component. The tibial component is the prosthetic piece that connects to the shin bone. The polyethylene, or plastic insert, is the piece that connects the tibial component and the talar component and serves as a cushion for the replaced ankle device. The talar component is the metal piece that connects to the foot bone.

How does the plastic insert defect affect a patient’s body?

When the plastic insert suffers from oxidation, it increases the wear and tear on the ankle replacement device. This leads to early device failure and causes patients to experience unbearable pain. Some of the painful consequences that patients experience from early device failure are a nerve injury, loosening of the joint, and infection.

One of the common signs is loosening when prosthetic devices eventually fail because the metal parts continue to collide with the bone. The majority of devices will eventually wear down and loosen over time.

Another potential serious injury is nerve injury. When ankle replacement surgery occurs, the nerves and blood vessels are in danger of becoming injured due to how close the nerves and blood vessels travel around the ankle joint. If either the nerves or blood vessels are injured, it is possible that the injury can become permanent. Patients with a defective ankle replacement device can experience additional issues like ankle swelling, pain in the ankle joint, and a grinding noise within the joint.

What should patients with a defective ankle replacement device do?

Patients who are not experiencing these types of symptoms with an Exactech ankle replacement device will not be recommended to pursue corrective surgery. Patients who are experiencing these types of symptoms will be required to pursue corrective surgery. Patients also have the option of filing a claim for reimbursement of any out-of-pocket expenses related to the corrective surgeries. However, by filing a claim, patients may waive their right to file a product liability claim against Exactech in the future.

Contact Kwartler Manus, LLC Today

No one should have to live with pain from a defective ankle replacement device for the rest of their lives. Let us help you hold your medical professionals accountable. Our Philadelphia attorneys will review your case, build an aggressive strategy, and fight for your patient’s rights. We aim to do our part in helping you recover, and will work to obtain the compensation you deserve. Call our Philadelphia cosmetic injury lawyers at (267) 457-5570, or fill out our contact form to discuss your case today.

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