Urgent Exactech Recall of Defective Hip Liner

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.

Exactech hip replacement recall

“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.

hip replacement surgery recall

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.

Total knee replacement surgery

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.

Metal on Metal Hip Replacements Linked to Serious Neurological Side Effects

A 2017 Health Watch study reported that elevated blood metal levels from metal-on-metal hip replacements are toxic to the brain. The findings of this research confirm an alarming and previously unknown risk of metal-on-metal hip replacements known as Arthroplasty Cobalt Encephalopathy (ACE).  This condition includes a number of serious neurological side effects, including mood swings, tremors, fatigue, balance issues, vision and hearing loss, as well as other cognitive problems.

Since the introduction of metal-on-metal hip implants to the marketplace, doctors and patients have discovered the harm they cause by increasing metal levels found in the human body. Most complications with metal hip implants are caused by high metal levels in a patient’s bloodstream, which doctors diagnose as metallosis. This condition occurs when the cobalt-chromium components of the hip implant grind together, breaking off metal fibers that are then released into the body. These metal fragments migrate through the bloodstream and reach the brain, causing ACE.

In general, doctors diagnose ACE by using blood tests and PET scans. However, diagnosing the link between a metal-on-metal hip replacement and cognitive decline associated with ACE can prove challenging. First, although the onset of neurological symptoms can be an early indicator of elevated metal levels in the blood, the diagnosis of ACE can be easily overlooked, as early neurological evaluations do not typically include a blood panel analysis. Moreover, even if blood tests are conducted as part of a neurological evaluation, studies show ACE presents in patients with levels below the range normally associated with a metallosis diagnosis.  Additionally, another difficulty in diagnosing ACE exists for older patients. Although not related to age, ACE symptoms such as memory loss and tremors can be too easily labeled as dementia. If an older metal-on-metal hip implant patient experiences ACE caused neurological changes, they may be overlooked and misdiagnosed as part of the aging process. As a result, the importance of monitoring blood metal levels in metal-on-metal hip replacement patients is absolutely critical.

Manufacturers of metal-on-metal hip replacements ignored the risks of introducing dangerous metal alloys into the human body. Because of these defective products, many individuals have experienced serious and harmful neurological side effects. Our product liability lawyers seek justice for people whose everyday lives have been affected by these unsafe medical devices. If you or a loved one has suffered injuries from a metal-on-metal hip implant, you may be entitled to compensation. For a FREE and confidential consultation, call the Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529).

Stryker Rejuvenate and ABG II Modular Hip System Recall

Thousands of Americans receive hip replacements every year due to sports injuries, falls, aging and a host of other reasons. The goal of a hip replacement surgery is to return to your active lifestyle as quickly as possible. There are many different hip replacement medical devices on the market, from plastic implants to metal on metal implants.

Over the past decade, there have been a number of recalls on many of the top, name brand, metal on metal hip implant devises. It is the FDA’s duty to be the guardhouse for safe products, but sometimes defective products are passed through the system due to inadequate testing, manipulated reporting and of course, from human error.

Stryker is letting patients know that they should undergo a hip revision surgery to replace their metal on metal hip device for another model. Stryker will cover the cost of the revision surgery, but there is more to having a revision surgery then the procedure alone. There is prep time, the surgery itself, the recovery time and the hopes that the revision surgery will go well and not create any further medical problems.

Unfortunately, sometimes, medical devices and pharmaceutical drugs get fast tracked through the system, meaning the FDA approves them for market use, before enough research and testing has been conducted.

This is what happened with many metal on metal hip implant devices. The FDA approved them all, but as they were used, more and more adverse reaction reports were being sent to the FDA, so an investigation began. Usually this takes years for a medical device or prescription drug to be recalled off the market. And while the FDA waits, innocent patients continue to be harmed.

Over two years ago, on July 6, 2012 Stryker issued a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems due to the increased potential for neck-body dissociation and increasing amounts of metal debris generated and deposited by the device.

Long-term toxicity of metal particles is not well known, but doctors have expressed concerns about metal exposure and there are numerous reports showing significant effects on organs. Metal toxicity has been linked to serious illnesses and is a very real concern for patients.

The modular interface of the Rejuvenate and ABG II creates corrosion, causing an inflammatory response, which results in a local reaction, such as metallosis, eventually affecting the entire body. Many patients have suffered a range of adverse reactions, such as:

  • Osteolysis (bone dissolution)
  • Synovitis (inflammation of the synovial membrane)
  • Pseudo-tumors
  • Fluid in the joint
  • Tissue and bone necrosis
  • Hypersensitivity to metal

Adverse reactions that affect the entire body include:

  • Decreased total lymphocyte cells, which defends against tumors and virally infected cells
  • Decreased CD8+T cells, which fight intracellular pathogens and malignancies
  • DNA changes
  • Chromosomal aberrations

If you have a Stryker Rejuvenate or Stryker ABG II implant and require a revision surgery call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529). We’ll speak with you for free to discuss your situation and help you to understand your rights.

If we take your case we will do so on a no win/no fee or expense basis only. That means you do not pay a fee or expense unless you recover.

Call now for a free confidential consultation.

The Yost Legal Group, Experienced Lawyers Dedicated to Protecting your Rights.