Urgent Exactech Recall of Defective Hip Liner

Exactech, a Florida based medical device manufacturer, has issued an FDA recall of a number of its medical devices. The recall list includes Optetrak, Optetrak Logic, and Truliant knee replacement products, Vantage ankle replacement products, as well as the Connexion GXL Hip Liner. The recall is prompted by the plastic in these products wearing out much faster than expected and causing the devices to fail. Most of these products were marketed to last 15 to 20 years but are failing much earlier. The failure leads to pain and complications that usually require an additional revision surgery to correct the problems caused by these defective products. Lawsuits are being filed for victims injured by the recalled products.

“Enhanced” Polyethylene Wears Out Causing Bone Damage 

Exactech uses a special type of polyethylene in their products known as: UHMWPE (Ultra High Molecular Weight Polyethylene). Exactech claimed that this “enhanced polyethylene” enabled their products to wear less and last longer than the standard polyethylene used by other orthopedic implant manufacturers. The opposite has proven true.

The industry standard for orthopedic implants is cross-linked polyethylene. Cross-linked plastic is treated with gamma or electron beam irradiation creating harder, stronger, more wear-resistant plastic. Vitamin E was added to the material in the mid-2000s, which further improved hip liner longevity. This design has been patented, leading some manufacturers such as Exactech to design their own version of this plastic in order to avoid paying patent fees. This is where Exactech’s Ultra High Molecular Weight Polyethylene comes into play. Exactech created this as a way of saving money. However, due to poor manufacturing, the actual resulting polyethylene was not treated the way the patented cross-linked polyethylene is during production. This resulted in the existence of free radicals of the surface of the plastic, making it more susceptible to oxidation.

Exactech claimed that the packaging the product was in caused the early oxidation, however, the product is meant to be resistant to oxidation, since it will still encounter oxygen while implanted inside the body. The failure of this plastic, and by association- Exactech products, is the result of cutting corners to save money. This could have been avoided had Exactech used the patented cross-linked polyethylene that has proven to be highly successful in orthopedic implants. Instead, countless individuals suffered harm simply to save the company a couple of bucks.

Exactech Connexion GXL Hip liner

Exactech’s Connexion GXL hip implant is a medical device used in total hip replacements. This is a “metal on plastic” hip implant, featuring an acetabular liner made of a plastic known as polyethylene. These implants are failing due to the polyethylene liners deteriorating. The deterioration exposes the metal, causing the metal components within the implant to rub together and break down prematurely.

Studies by orthopedic surgeons of the Exactech Connexion GXL liner published in medical journals have shown that this defective liner is prone to early failure. When the plastic wears out, it causes severe bone damage called osteolysis.

Symptoms of the Device Failure include:

  • Difficulty walking
  • Loosening of the implant
  • Joint Stiffness
  • Swelling and inflammation
  • Possible bone degeneration: osteolysis
  • Extreme Pain

High Failure Rates Leads to FDA Recall

In June of 2021, Exactech finally recalled the Connexion GXL liner because of the concerns raised by the medical community about its high failure rates from wear causing severe osteolysis. This recall affected roughly 90,000 patients with the Connexion GXL Liner. Exactech also sent doctors an “urgent communication” letter warning about the higher failure rates.  In fact, Exactech recommended that Connexion GXL patients follow up with their doctor if they had received their hip implant in the last six years and had not had a follow appointment in the past 12 months.

Optetrak, Optetrak Logic, and Truliant Knee Implants

Along with the Connexion GXL Liner, the recall also included 60,926 Exactech Optetrak knee implants, 60,518 Exactech Optetrak Logic knee implants, 24,727 Exactech Truliant knee implants, impacting nearly 150,000 patients with these products. The same defective polyethylene inserts were also used in 1,561 Exactech Vantage ankle replacement systems, which have also been recalled.

The Optetrak, Optetrak Logic and Truliant Knee replacement systems are what is considered a metal on plastic device, where the polyethylene is used between the metal components to cushion the joints. When the polyethylene oxidizes this causes the device to break down, debris to break off into the body, bone loss, and more.

Symptoms of a failing knee or ankle system include:

  • Pain
  • Swelling around the joint
  • Accelerated wear
  • Component fatigue
  • Component fracturing
  • Debris production
  • Osteolysis (bone loss)
  • Bone Fractures
  • Instability in the knee or ankle
  • Inability to bear weight

If you have an Exactech knee or ankle implant and are experiencing any of these symptoms, you may be entitled to financial compensation.

Exactech Attempts to Limit Rights of Patients

Following the recall, Exact hired the company Broadspire to contact individuals with their recalled products to see if they were having complications and would need a revision surgery. For those persons suffering from complications, Broadspire offers compensation, but only to cover the cost of the revision surgery. In exchange for compensation, these individuals must waive their rights to any future legal action against Exactech, preventing them from recovering payment for the pain and suffering they have experienced.

Exactech hired Broadspire to save the company money. They are looking out for Exactech, not persons harmed by the device. If you have any of the recalled Exactech products and are suffering from complications DO NOT sign an agreement with Broadspire. Doing so will waive your right to claim full compensation for the pain; and suffering caused by this Exactech defective product.

You May Have a Claim for Compensation

If you or a loved one has been implanted with any of the recalled Exactech products, call The Yost legal Group at 1-800-YOST-LAW (1-800-967-8529) today for a free consultation or email us at info@yostlaw.com. Our experienced Exactech lawyers can help you pursue your Exactech claim. We are investigating claims for individuals who are seeking Exactech settlements. There is no fee or expense unless you recover.