Weitz & Luxenberg is representing clients needing a revision surgery due to failure from an Exactech knee implant. Potential clients may be suffering from osteolysis (bone loss), loosening, lysis, swelling, difficulty walking, and pain associated with polyethylene wear.
The defective devices, containing Exactech Knee and Ankle Ultra-High Molecular Weight Polyethylene, were recalled by the manufacturer. They include specific OPTETRAK®, OPTETRAK Logic®, and TRULIANT® tibial inserts and components, as well as VANTAGE® fixed-bearing liner components. The tibia is your shinbone.
“It is simply wrong when companies which manufacture defective medical devices that are implanted into patients do not act with appropriate care to ensure these devices are safe. It is horrible that our clients who have already undergone a substantial surgery, a knee or ankle arthroplasty, are being told they need another one because of an easily preventable manufacturing and packaging error,” states Ellen Relkin. “The damage caused by this polyethylene, osteolysis, has destroyed bone in many patients, resulting in not only the need for a revision surgery, but also the use of bone grafting which in some cases cannot cure the extensive loss of bone.” Ms. Relkin is a partner at Weitz & Luxenberg and our practice group chair for defective drugs and medical devices.
Ms. Relkin has been working for decades with clients who have implant failures. Recently, she has been handling cases on another Exactech defective device, the Exactech Connexion GXL Acetabular Liners. She has been a court-appointed lead for many litigations involving other failed implants.
Recall Due to Complications from Devices
Exactech quietly began this recall in August, 2021, and is now expanding it. The recall includes total knee replacements and total ankle replacements with components and inserts made of polyethylene. This is a type of plastic.
The U.S. Food and Drug Administration (FDA) classified this as a Class II recall, according to Exactech. The FDA partially defines a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.” (1)
Exactech acknowledges early wear due to the liners and components. The company’s recall announcement includes a letter to surgeons, indicating the “Optetrak Knee system has shown statistically significant higher overall revision rates as compared to other TKA’s in the Australian, United Kingdom and New Zealand registries.” (2)
The company’s letter also states, “surgeons should maintain an appropriate index of suspicion for patients with any new or worsening pain, inability to bear weight, grinding or other noise, swelling, or instability in their knee or ankle.” (3)
Problems with the Exactech Device
Beginning in 2004, these devices came in vacuum bags missing a secondary barrier layer. The second layer, when present, contains ethylene vinyl alcohol. Exactech indicates it helps enhance the initial layer’s oxygen resistance.
Exactech explains, “one of the packaging layers for the plastic insert… may allow oxygen from the air to diffuse into the plastic insert prior to it being implanted in your knee… .this can lead to a process called oxidation, which can cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.” (4)
Helping Clients Facing with Recall Exactech Liners
The defective medical device team of attorneys at Weitz & Luxenberg is inviting anyone who needs a revision surgery due to this Exactech recall to reach out to us.
Potential clients should also contact our team if they have been having problematic symptoms such as pain, stiffness, and limited mobility, after being implanted with this Exactech device.
If you are, you are not alone. “There are approximately a total of 147,732 inserts implanted in the US since 2004 that were produced with non-conforming packaging.” (5)
Feel welcome to contact our attorneys using our online form or by phone at (833) 544-0604. Your initial consultation is free.
We have been able to successfully win more than $12 billion in drug and medical device litigations for our clients. Call and find out what we can do to get justice for you.