Exactech Knee Replacement Lawsuit

Exactech recall lawsuits were pursued for individuals throughout the United States who faced an increased risk of knee replacement failure and complications caused by a defective plastic insert included with more than 147,000 Exactech knee implants distributed since 2004.

The lawsuits alleged that polyethylene inserts sold with the Optetrak, Optetrak Logic, and Truliant total knee replacements were packaged in defective vacuum bags that allowed oxygen to diffuse into the plastic inserts during storage. This oxidation degraded the material before it was implanted, increasing the risk of:

• Accelerated Knee Wear
• Debris Production
• Bone Loss
• Cracking, Fracture or Component Fatigue
• Additional Knee Revision Surgery

Financial compensation and Exactech lawsuit settlements were pursued for individuals who received the recalled implants, regardless of whether they had already experienced complications. Many lawsuits were consolidated as part of a multidistrict litigation (MDL), where plaintiffs alleged Exactech failed to adequately warn patients and doctors about the long-term risks associated with the defective packaging process.

What are average Exactech knee settlement amounts?

While there have not been any publicly disclosed Exactech knee settlement payouts, prior cases involving defective joint implants often resulted in settlements ranging from $50,000 to $250,000, depending on the severity of the injury and the impact on the individual’s quality of life. In cases involving more severe complications, higher compensation was sometimes awarded.

The types of damages commonly sought in the Exactech knee lawsuits included:

• Reimbursement of medical expenses, including costs of revision surgery and ongoing care

• Lost income and diminished earning capacity related to recovery time or permanent impairment

• Pain, suffering, and loss of enjoyment of life due to mobility issues and repeated surgeries

• Punitive damages, aimed at holding Exactech accountable for alleged failure to warn about packaging defects

Although Exactech offered to reimburse some “out-of-pocket” surgical expenses following the recall, many plaintiffs sought broader compensation through the courts to address the full scope of physical, emotional, and financial harm caused by the recalled knee implants.

Exactech Knee Replacement Recall Information

On February 7, 2022, an Exactech knee replacement recall notice was sent to orthopedic surgeons throughout the United States, providing information about 147,732 defective and dangerous knee inserts implanted in patients since 2004. The manufacturer also provided a sample recall letter that should be sent to all individuals who may be impacted by the defective implant.

The action has been categorized as a class II medical device recall, meaning that individuals who received a recalled knee replacement face a risk of serious, but medically reversible health problems, often resulting in the need for additional knee surgery. This may leave users with unnecessary medical bills, pain and suffering, and facing an increased risk of knee replacement problems that could have been avoided.

What Recalled Knee Replacements are Part of the Exactech Lawsuit?

After initially recalling a limited number of Exactech knee replacement polyethylene inserts in August 2021, the recall has now been substantially expanded. It now includes Exactech Optetrak knee replacements sold since 2004, Exactech Optetrak Logic knee implants sold since 2009 and Exactech Truliant knee systems sold since 2017, regardless of label or shelf-life remaining.

Exactech Optetrak Knee Recall

The Exactech Optetrak knee was introduced in the United States in 1994. However, after it was on the market for about ten years, changes were made to the manufacturing process for vacuum bags used for polyethylene inserts with Exactech Optetrak knee implants. Therefore, all Exactech knee replacements since 2004 may be impacted by the recall.

At least 60,926 Exactech Optetrak knee implants have been recalled, including:

• Exactech Optetrak CR Tibial Components
• Exactech Optetrak PS Tibial Components
• Exactech Optetrak CR Tibial Inserts
• Exactech Optetrak CR Slope Tibial Inserts
• Exactech Optetrak PS Tibial Inserts
• Exactech Optetrak HI-FLEX PS Tibial Inserts

Exactech Optetrak Logic Knee Recall

In 2009, the Exactech Optetrak Logic knee replacement was introduced, involving a unique surgical technique and knee implant system intended to preserve bone and meet the demands of more active patients.

At least 60,518 recalled Exactech Optetrak Logic knee replacement products contained the same defective plastic insert, including:

• Exactech Optetrak Logic CR Tibial Inserts
• Exactech Optetrak Logic CR Slope Tibial Inserts
• Exactech Optetrak Logic CRC Tibial Inserts
• Exactech Optetrak Logic PS Tibial Inserts
• Exactech Optetrak Logic PSC Tibial Inserts
• Exactech Optetrak Logic CC Tibial Inserts

Exactech Truliant Knee Recall

Exactech Truliant knee implants were introduced in 2017, for use during primary total knee replacements or knee revision surgery.

At least 24,727 Exactech Truliant knee replacements were implanted that are now included in the 2022 recall, including:

• Exactech Truliant CR Tibial Insert
• Exactech Truliant CR Slope Tibial Insert
• Exactech Truliant CRC Tibial Inserts
• Exactech Truliant PS Tibial Inserts
• Exactech Truliant PSC Tibial Inserts

Exactech Ankle Replacement Recall

Similar polyethylene inserts used with recalled Exactech knee implant were included with the Exactech Vantage ankle replacement system, which was introduced in 2016. As of February 2022, at least 1,561 of these defective ankles implanted in the United States have now been recalled, and our lawyers also investigated Exactech ankle replacement lawsuits.

Exactech Hip Replacement Recall

Separate from the Exactech Optetrak recall, a warning was issued in June 2021 about 89,050 Exactech Connexion GXL liners used since 2017 with Exactech Novation and Acumatch hip replacements.

Just over a year later, an August 2022 Exactech hip implant recall expansion was issued, indicating there are problems with another 40,000 liners, including Acumatch GXL Acetabular Liners, MCS GXL Acetabular Liners, Novation GXL Acetabular Liners, Exactech All Polyethylene Cemented Acetabular Cup, Acumatch Conventional UHMWPE, MCS Conventional UHMWPE and MCS Conventional UHMWPE liners.

What was the problem with Exactech knee implants?

Exactech lawsuits claimed that individuals who received certain recalled knee implants since 2004 faced an increased risk of complications with the Optetrak, Optetrak Logic, or Truliant knee replacement systems. These problems often resulted in the need for premature revision surgery after symptoms of implant failure developed.

A total knee replacement system consists of several key components that work together to restore function in the knee joint:

• Femoral Implant: metal piece that attaches to the thigh bone, known as the femur.
• Tibial Tray: metal piece that fits into the tibia or shin bone.
• Patellar Component: plastic piece that fits onto the knee cap or patella.
• Tibial Polyethylene Insert: plastic insert that fits between the femoral and tibial components to act as a cushion for the artificial knee joint.

The primary issue with Exactech’s recalled knee systems involved the polyethylene insert, which serves as the shock absorber in the artificial knee joint. If this insert degrades or fails, the entire knee replacement may become unstable or painful, often requiring corrective surgery.

The Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) inserts were packaged in vacuum bags that lacked a critical oxygen-resistant barrier. These “out-of-specification” bags did not contain an additional ethylene vinyl alcohol (EVOH) layer, which is used to prevent oxidation of the plastic over time.

As a result, oxygen could reach the polyethylene inserts during storage or transport, leading to oxidation that compromised the integrity of the material. This degradation increased the risk of:

• Accelerated knee wear
• Debris production
• Bone loss
• Component cracking, fracture or fatigue
• Additional knee revision surgery

Symptoms Reported With Exactech Knee Failures

Individuals with recalled Exactech knee implants reported a variety of symptoms that were later linked to premature wear or failure of the polyethylene insert. These included:

• New or worsening knee pain
• Knee swelling
• Pain while walking
• Inability to bear weight
• Knee instability
• Grinding, clicking or other noises from the knee implant

In many cases, physicians recommended knee revision surgery to remove and replace the defective components. In some situations, surgeons were able to preserve other parts of the knee implant and only replace the polyethylene insert with a properly packaged version that included the necessary oxygen barrier.

Knee Replacement Lawyers

Following the recall of Exactech Optetrak, Optetrak Logic, and Truliant knee implants, individuals who underwent total knee replacement surgery since 2004 were encouraged to explore their legal rights and pursue compensation for complications caused by the defective polyethylene inserts.

The Exactech knee lawyers at Saiontz & Kirk previously provided free case evaluations to help individuals determine whether they may qualify for a lawsuit settlement. Representation was offered on a contingency fee basis, meaning clients paid no fees unless a recovery was obtained.

It was not necessary for individuals to know the specific type of knee implant used during their surgery before contacting the firm. The legal team helped review medical records and identify recalled components involved in the procedure.

Each case was evaluated based on the circumstances surrounding the knee replacement and the extent of complications. Those found eligible were given the option to retain legal representation and pursue a claim for compensation through the Exactech litigation.