New York Exactech Lawyer: Knee, Hip, and Ankle Replacement Lawsuits

Exactech Recall Lawsuit

In February of 2022, Exactech issued a recall of all polyethylene tibial hip, knee, and ankle inserts manufactured in 2004 or later due to being placed in defective vacuum packaging that caused premature oxidation.

According to the company, Exactech replacements comprised of proprietary polythene materials, which require special care to prevent oxidation.

Premature oxidation is dangerous and causes the insert to degrade, leading to:

• Bone loss
• Accelerated wear
• Debris production
• Noises such as clicking, popping, or grinding
• Inability to bear weight
• Component fatigue
• Cracking and fracture
• Increased need for revision surgery

Degradation can occur both on the shelf or after receiving the implant due to oxygen carried in the blood and synovial fluid.

Recipients of faulty implants are more likely to experience pain, swelling, stiffness, or difficulty moving the joint due to bone loss.

Who Qualifies

You may qualify to file an Exactech recall lawsuit if you suffer from complications due to having received a recalled knee or ankle replacement.

If you believe you received a faulty implant, contact your surgeon and confirm your device’s serial number on Exactech’s recall page to see if you are eligible for compensation.

Recalled Components

If you received an Exactech knee, ankle, or hip implant, you may be at risk. Polyethylene components have been recalled from the following systems:

Knee and Ankle Polyethylene

• Optetrak®
  All-Polyethylene Tibial Components
  Hi-Flex® Polyethylene Tibial Inserts
  Custom Polyethylene Tibial Inserts
• Logic® Polyethylene Tibial Inserts
  RBK® Polyethylene Tibial Inserts
  Logic RBK Tibial Components
• Arthrofocus® Polyethylene Tibial Inserts
• Truliant® Tibial Inserts
• Vantage® Fixed-Bearing Polyethylene Liner Component and Mobile-Bearing Polyethylene Liner Component

Connexion GXL and Conventional Hip Liners

• Acumatch GXL Acetabular Liners and Conventional UHMWPE
• MCS GXL Acetabular Liners and MCS Conventional UHMWPE
• Novation GXL Acetabular Liners
• Exactech All Polyethylene Cemented Acetabular Cup

What to Do If You Were Impacted

The Jacob Fuchsberg Law Firm recommends that you monitor your implant for symptoms of failure, including pain, swelling, or difficulty moving the joint. If you find yourself experiencing any of these symptoms, contact your doctor immediately.

Even if you are not experiencing pain but did receive an Exactech implant, contact your surgeon to discuss a long-term plan to monitor your implant.

Exactech Multidistrict Legislation (MDL)

Exactech Obtained Fast-Track FDA Approval

Exactech obtained fast-track FDA approval for their knee replacement and implant systems from 1994 to 2017. Fast-track approval, otherwise known as 501(k) clearance, does not require the manufacturer to prove the safety and effectiveness of a product. 

Exactech touted the Optetrak Logic system as being first-in-class, high-performing, and having key benefits including long-term implant survivorship. As a result, at least 145,484 defective devices were distributed and inserted into unknowing patients, putting thousands of people at risk of early failure. 

For many years prior to the recall, academic and clinical studies showed that Exactech devices had higher than expected revision rates and performed poorly when compared to its competitors. In addition, we believe there were feasible alternative designs and manufacturing options available to the defendants to decrease or eliminate oxidation from occurring.

Exactech Cases Consolidated into MDL

On February 7, 2022, Exactech officially issued a recall of polyethylene liners manufactured in 2004 or later. The recall was issued by the FDA after confirming that non-conforming packaging increased the risk of early degradation and failure. 

After the recall was announced, patients who received lawsuits began to file numerous product liability lawsuits against Exactech, and as a result, the Judicial Panel on Multidistrict Litigation officially consolidated all Exactech joint replacement recall lawsuits into a class action MDL centralized in the Eastern District of New York. The MDL has been assigned to Judge Nicholas G. Garafuis. 

In December of 2022, Judge Garafuis appointed 27 experienced Exactech recall lawyers, including our own Eli Fuchsberg to serve in various positions and aid with the multidistrict litigation. 

As of July 2023, there are 395 pending cases in the Exactech class action MDL, however, more cases are expected to be filed.

Choosing an Exactech Lawyer

The Jacob Fuchsberg Law Firm is currently representing clients who were wrongfully impacted by defective Exactech devices. Our team of experienced Exactech lawyers can help you recover damages for medical bills, loss of future income, loss of wages, as well as pain and suffering. In some cases, we can help your spouse seek damages by claiming companionship.

If you received a recalled implant, contact the Jacob Fuchsberg Law Firm to speak with an experienced Exactech lawyer for a free consultation.

“Choose an Exactech lawyer who is experienced in recalled medical device lawsuits and fighting against big medical device companies. Because Exactech lawsuits have been consolidated in multidistrict litigation, it also helps to hire a lawyer from a national firm with the resources and leadership experience in MDLs.” – Drug Watch