Some of the most routine surgeries performed in many hospitals are knee, hip, and ankle replacements. There are over 600,000 knee replacement surgeries carried out by surgeons every year in the United States. Medical industry statistics reveal that over 2.5 million patients live with hip implants.
Although ankle replacements are the less common of the three replacements, there are more and more ankle replacements being performed every year. However, the safety of many patients with knee, hip, and ankle replacements is at risk due to a massive recall from Exactech, a medical device company that produces devices for joint replacement.
What Exactech medical devices are being recalled?
Exactech recently issued a recall last month concerning thousands of polyethylene plastic inserts that are used in knee and ankle replacements. The products that are recalled are the Exactech Ultra-High Molecular Weight Polyethylene Knee and Ankle Polyethylene Inserts. These inserts are positioned between the metal components of a patient’s knee or ankle replacements and help to cushion the joints. The defective inserts have been discovered in knee and ankle replacement systems like Truliant, Vantage, Optetrak, and Optetrak Logic.
What Exactech hip replacement devices have been recalled?
Last summer, Exactech also had to recall some models of a liner included in the hip replacements. The acetabular liner is a form of plastic or ceramic component that is often inserted into an acetabular cup. It is attached to other hip components that are attached to the hip replacement. The acetabular liner was recalled due to early device failure. Orthopedic surgeons at the Department of Orthopedics and Rehabilitation issued a study revealing the early failure of the acetabular liners due to wear.
Why were these devices recalled?
These inserts were recalled due to out-of-specification packaging that failed to properly protect the inserts from being exposed to oxygen. The company’s Urgent Medical Device Correction letter declared that once the inserts are exposed to oxygen, the inserts are at risk of degrading over time and increasing the chances of early device failure.
Regardless of the shelf life, all knee and ankle inserts that have been packaged in out-of-specification bags have been recalled. The inserts that were manufactured in 2004 were confirmed to be packaged in out-of-specification bags. Currently, the number of devices that have been implanted in the United States from 2004 have been nearly 147,732.
How do these defective devices harm the patients?
The recalled knee and ankle inserts can cause patients to experience serious pain. Some of the pain that the recalled devices can cause patients are bone loss, accelerated wear, component fatigue, and component cracking. The patients may require corrective surgery to have the devices removed.
Exactech’s history of recalls
Unfortunately, this is not the first recall that the company has dealt with. Exactech also had to recall an Optetrak knee implant device where patients were experiencing the same type of pain. Patients complained of experiencing instability, early device failure, and requirements of corrective surgery. Past lawsuits against Exactech revealed that the company was aware of the problems with the devices, but decided not to warn the consumers and intentionally continued to sell the defective implants.
Steps for consumers with recalled devices to take
If patients with recalled Exactech knee or ankle implants are experiencing pain, swelling, instability, or any new symptoms of clicking with the knee or ankle, patients are advised to contact their health providers for an evaluation. Healthcare providers may opt to contact patients with these devices on their own accord to ensure that the devices are still working properly.
Exactech does not recommend corrective surgery for patients who are experiencing symptoms of pain or issues with walking. Instead, the company has provided instructions on their website on how patients can file a claim for reimbursement related to the recalled implants.
Contact Kwartler Manus, LLC Today
No one should have to live with a defective medical device causing them harm for the rest of their lives. Let us help you hold your medical professionals accountable. Our Philadelphia defective medical device 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 office at (267) 457-5570 to schedule a consultation.