Exactech announced the recall of some of its most popular knee and ankle replacement products, implanted into hundreds of thousands of patients between 2004 and 2022. According to the recall notice—published by both Exactech and the federal Food and Drug Administration (FDA)—some joint inserts suffered from critical packaging defects that damaged parts before they were ever used in the operating room. Patients have since reported a wide range of troubling symptoms, from unusual noises to mild inflammation and bone loss, forcing many to spend more money on revision surgery and other treatments.
DeLoach, Hofstra & Cavonis, PA, have a half-century of experience fighting for Florida’s rights. If you or a loved one were injured by a faulty Exactech insert, our experienced team of class action attorneys can help you assert your rights, fighting for the compensation you need and the relief you deserve.
Understanding the Exactech Hip and Knee Recall
Exactech, a medical device manufacturer, announced its recall of certain hip and knee replacement inserts on February 7, 2022.
The recalled products include, but aren’t limited to, artificial joint inserts sold under the following names:
- Optetrak
- Optetrak Logic
- Truliant Knee Replacement
- Exactech Acumatch
- Exactech MCS
All of these products, used in either hip or knee replacement devices, are believed to have been compromised by a set of serious packaging defects. These defects left products exposed to oxygen.
Under most circumstances, companies like Exactech vacuum-seal surgical inserts and other sensitive medical devices. However, while Exactech did seal its recalled products, it failed to integrate a second barrier against oxidation—an obvious oversight that has led to widespread product failure.
If and when Exactech medical devices are exposed to oxygen, their components can oxidize and degrade. Oxidation, even in the short term, can cause “accelerated wear, debris production, bone loss, component fatigue, and component cracking or fracture,” according to the company and the FDA.
Potential Exactech Hip and Knee Device Injuries
The FDA has categorized the ongoing Exactech recall as a Class 2 recall, meaning that product-related injuries may cause “temporary or medically reversible adverse health consequences.”
Patients who received defective hip and knee inserts report symptoms including, but not limited to:
- Swelling
- Mild to severe pain
- Bone loss
- Premature wear or device failure
- Loosening of joint replacement components
Some of these symptoms, like bone loss, have long-term consequences, increasing patients’ lifetime risk of chronic disability. Although Exactech and the FDA stress that most insert-related injuries are “medically reversible,” recovery often entails yet another trip to the operating room, placing immense pressure on families’ finances.
Asserting Your Rights After an Exactech Injury
The costs of an Exactech-related injury can be enormous, especially for patients struggling to obtain insurance coverage or approval for a revision surgery. Even when coverage is granted, some victims may incur additional costs, whether because they’re forced to take time away from work or because they’re responsible for a high co-pay.
However, Floridians injured by a defective knee or hip insert may have options beyond further financial strain. Medical device manufacturers such as Exactech have a legal obligation to ensure that their products are safe. If a replacement joint is inherently unsafe, product-makers may be found liable for the costs of any resulting damages, even if they were unaware of the presence of a defect.
If you or a loved one suffered because of a defective Exactech knee or hip replacement device, here’s how to protect your rights.
1. Collect Your Records
If you have any medical records relating to your original knee replacement—such as surgical orders, PTO requests, or a recommendation for revision surgery—collect them and store them in a safe place.
2. Listen to Your Doctor
The Exactech recall suggests that most physicians had no reason to believe that the replacement devices they implanted in patients were in any way unsafe. Share your concerns with your doctor, and continue following their advice.
3. Speak to an Attorney
Before contacting Exactech or paying out-of-pocket for revision surgery, consult with DeLoach, Hofstra & Cavonis, PA, and our experienced team of class action consumer issue attorneys. We’ll help you explore options for a more holistic legal recovery—a recovery that could include payment of your anticipated medical costs, as well as compensation for your other losses.
