Exactech Recall Lawsuit; Connexion GXL Hip Replacement Liner
Exactech, a Florida based medical device manufacturer, has issued an FDA Exachtech recall of a number of its medical devices. The recall list includes:
- Optetrak
- Optetrak Logic
- Truliant knee replacement products
- Vantage ankle replacement products
- Connexion GXL Hip Liner
The hip implant recalls are 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 additional revision surgery to correct the problems caused by these defective products. Exactech lawsuits are being filed for victims injured by the recalled products.
“Enhanced” Polyethylene Wears Out Causing Bone Damage and Potential Hip Replacement
Exactech uses a special type of polyethylene in its products known as UHMWPE (Ultra High Molecular Weight Polyethylene). Exactech claimed that this “enhanced polyethylene” enabled its 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, and more wear-resistant plastic.
Vitamin E was added to the material in the mid-2000s, further improving hip liner longevity. This design has been patented, leading some manufacturers, such as Exactech, to design their own version of this plastic 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 was during production.
This resulted in the existence of free radicals on the plastic’s surface, making it more susceptible to oxidation. The oxidation then led to knee implant failure and hip implant failure. Thus leading to hip replacement complications and knee replacement complications.
Exactech’s Cost-Cutting Measures Lead to Critical Hip Replacement Failures
Exactech claimed that the product’s packaging caused 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 and had to undergo a hip replacement simply to save the company a couple of bucks.
Many patients have to undergo a revision hip implant surgery and a revision total knee revision surgery. The cost-cutting measures created range of motion problems, soft tissue problems, and diminishing quality of life for many.
Exactech Connexion GXL Hip liner lawsuit
Exactech’s Connexion GXL hip implant is a medical device used in total hip replacements. It is a “metal on plastic” hip implant featuring a polyethylene plastic acetabular liner. 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, which often requires hip liner replacement surgery.
The Yost Legal Group is filing hip replacement lawsuits for individuals across the country. If you require a revision surgery of your joint replacement device, protect your rights by filing a lawsuit.
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 Lead to FDA Recall
In June 2021, Exactech recalled the Connexion GXL liner. This was because the medical community had concerns about its high failure rates from wear, which were leading to 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 considered metal-on-plastic devices.
Polyethylene cushions the joints between the metal components. When the polyethylene oxidizes, the device breaks down, debris breaks off into the body, bone loss occurs, and more.
Symptoms of a failing knee or ankle system present complications, including:
- 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
After the recall, Exactech hired a company, Broadspire, to contact individuals who had received the recalled products. They wanted to see if these individuals were experiencing any problems and if they might require additional surgery.
Broadspire offered minimal compensation for those suffering from complications, only to cover the cost of the revision surgery.
In return for a small payment, people had to give up their right to sue Exactech in the future. This meant they couldn’t get money for the pain they went through.
Exactech hired Broadspire to save the company money. They are looking out for Exactech, not the people harmed by their defective devices.
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 have a total knee replacement that has failed, you may qualify to file a lawsuit for financial compensation.
If you have one of the hip replacement recall devices, you may qualify to file a lawsuit.
If you had any joint replacement surgery that required being removed and replaced, call The Yost Legal Group to learn about your rights.
Do not sign anything from Exactech or Broadspire without speaking with an Exactech lawyer first. Doing so could limit your right to sue for full and fair compensation.
If you have questions, call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529) today. We will provide a free case evaluation, or email us at info@yostlaw.com.
Our experienced Exactech attorneys 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.
