Individuals with joint pain and arthritic issues know about Exactech. This medical device manufacturer specializes in joint replacement for people with injured or arthritic knees, ankles, shoulders, and hips. Recently, the company has been receiving customer complaints about its faulty devices, resulting in a growing number of lawsuits.
In September 2022, About Lawsuits reported a failure of Exactech’s Truliant knee replacement device. A faulty polyethylene insert packaging was the core issue. Gary Cheramie, a man from Louisiana, raised this complaint after choosing this knee replacement device. He shared his disappointment, stating that he needed additional surgery to remove the implant and replace it with a new one.
Gary is one of the many anguished patients who received a faulty knee implant and has filed an Exactech lawsuit. In March 2023, the U.S. Food and Drug Administration issued a reminder to healthcare providers and patients about Exactech joint replacement devices, which were manufactured between 2004 and August 2021 and recalled between 2021 and 2022.
Most knee, hip, and ankle replacement devices had faulty packaging bags. These bags didn’t have an oxygen barrier layer, which keeps the device secured from oxidation. It is a chemical reaction that causes rapid device failure, wear-and-tear, and component fracture or cracking, necessitating corrective revision surgery. Some of the recalled devices are linked to a high risk of bone loss and revision surgeries associated with device failure.
In April 2022, New York Injury Law News shared the story of a couple from Florida who filed a knee replacement lawsuit against Exactech in New York County. One partner had received the Optetrak Comprehensive Total Knee System and developed severe injuries later.
In January 2013, the plaintiff had undergone a complete left knee replacement. Her surgeon had implanted an Optetrak device with a tibial insert composed of polyethylene.
Several years later, she was diagnosed with aseptic loosening on her left knee. She was further diagnosed with osteolysis, a medical condition that destroys bone tissues. Both these problems led her to undergo high-risk revision surgery in May 2021. The surgery continued for six hours and kept her hospitalized for six days.
During the surgery, her surgeon noticed an increased amount of osteolytic tissue. Her thigh bone component was vastly loose. The surgeon could lift off her femur almost manually, and the tibial component was damaged too.
According to the plaintiff, her knee replacement damage resulted from a premature scraping of the shin bone insert. To date, she has mobility issues that add to her discomfort. She faces problems in her everyday activities such as bathing, climbing stairs, and even getting dressed.
But filing a lawsuit against a leading medical device manufacturer like Exactech can get challenging and tricky. TorHoerman Law states that a lawyer with relevant experience can help. Getting in touch with a lawyer for a consultation will enable victims to determine their legal moves better. Since these lawsuits are still in the initial stages, precise data on average settlement isn’t available.
However, individuals willing to file a legal claim should provide their lawyers with detailed medical records and evidence to develop a compelling legal case. It will help ensure favorable compensation.
Knowing that Exactech was aware of its loopholes and failed to act accordingly has added to every patient’s frustration and remorse. Nothing can be more upsetting for a patient than this situation.
Exactech claimed that Optetrak provided the best outcome for the long run. But it did not perform well compared to other similar devices. According to the Australian Orthopaedic Association, as an implant, Optetrak had the highest revision rate.
The Australian National Joint Replacement Registry stated that the revision rate for knee replacement with the Optetrak tibial component over a decade was 8.5. It exceeded the global guidelines for accepted revision rates.
Despite this, Exactech promoted and sold knee implants, claiming that they were safe and sound. The company didn’t change its labeling, product inserts, and marketing materials to alert physicians or patients about the allied risks.
In August 2021, the company issued a partial recall of its Optetrak polyethylene tibial components. Here Exactech clarified that the inserts were packaged in vacuum bags that lacked an extra oxygen protection layer. Finally, in February 2022, the company informed doctors about the recall of all the polyethylene tibial inserts.
Individuals with joint pain and other arthritic issues face daily challenges. Patients requiring a knee implant should not choose any device recalled by Exactech. Conducting thorough research and learning about other secure options will help to make an informed decision.
Additionally, if you already have an Exactech knee replacement implant that has caused extreme discomfort, consult a healthcare provider. Usually, patients feel swelling, acute pain, weakness, or a grinding noise around the implanted device. After receiving a medical diagnosis and treatment, it is essential to seek legal assistance.