Since 2004, nearly 150,000 patients in the United States have had a knee or ankle replacement with Exactech’s Optetrak, Optetrak Logic, Truliant, and Vantage implant systems. A recent recall highlights a product defect that could injure patients with those Exactech models.
Defective Liner Inserts
According to a company statement, these devices may fail prematurely due to improper packaging. “Out-of-specification” or “nonconforming” vacuum bags in which the products were enclosed allowed the plastic polyethylene inserts to be exposed to high oxygen levels, causing them to potentially degrade before implantation.
These inserts are placed between metal components in the knee and ankle replacements to cushion joints. Oxidation of the plastic inserts before implantation may result in premature degradation that could cause the device’s early failure, cracking, or breaking and the need for many patients to undergo revision surgery.
The Recall
Exactech began quietly recalling the defective devices on August 31, 2021. On February 7, 2022, it sent the “URGENT MEDICAL DEVICE CORRECTION” notice to surgeons and hospitals, informing them of the potential failure and the recall.
This is a Class 2 recall, which means the products may cause “temporary or medically reversible” health consequences. Exactech “recommended” that surgeons notify their patients of the recall and provided a draft letter for them to personalize and send out to patients who had received one of the Exactech knee or ankle replacement systems.
Signs and Symptoms of a Defective Exactech Knee or Ankle Replacement
You may need revision surgery to replace the insert if you were surgically implanted with one of the defective Exactech replacement systems and have suffered from the following symptoms, including:
- Bone loss that may require bone grafting.
- New or worsening swelling.
- Pain while walking.
- Stiffness or limited mobility.
- Inability to bear weight.
- Grinding or other noise in the knee or ankle.
- Instability.
- New symptoms of clicking in the knee or ankle.
- Debris around the knee or ankle.
Holding Exactech Accountable for Your Injury
Due to the product defects, Exactech saw a higher number of revision surgeries with its knee and ankle replacement systems than manufacturers of similar products. Consequently, Exactech knew or should have known of the packaging problem and should have taken steps to correct it much sooner than the recent recall.
Instead, Exactech allowed surgeons to implant patients with potentially defective replacement systems for 17 years before issuing the recall, a delay that caused many patients serious injury and severe pain and necessitates revision surgeries. These problems could have been avoided had Exactech properly packaged the inserts.
Contact an Attorney Experienced in Defective Medical Product Lawsuits
If you or someone you know has an Exactech knee or ankle replacement system under recall and suffers from any of the health problems associated with the defective knee or ankle replacements, please contact the defective device lawyers at Sommers Schwartz. We have over 45 years of experience representing patients harmed by health care providers and medical equipment manufacturers, including the prosecution of defective medical devices. We can help you recover compensation for your injury.
Robert B. Sickels
For more than 30 years, Robert Sickels has successfully represented plaintiffs involved in complex personal injury, medical negligence, and products liability matters.
