Product Liability

Exactech Issues Recall of Defective Orthopedic Device

July 17, 2022
Contributors

On July 9, 2022, The Jacob D. Fuchsberg filed two lawsuits against orthopedic device manufacturer Exactech on behalf of clients who were implanted with the company’s defective total knee replacement and revision devices.   

These Plaintiffs have endured years of extreme pain, swelling and stiffness due to what is believed to be failures of their Exactech devices. They required extensive medical care and multiple surgeries. The clients had and still have plastic defective components in their knees which the company has recalled due to the product’s propensity to degrade and fragment while in the Patients body.  

On February 7, 2022, the EXACTECH DEFENDANTS issued a recall of the subject knee device’s polyethylene tibial inserts due to Defendants’ use of non-conforming bags in the packaging of the plastic inserts which caused a substantially heightened risk of oxidation of the subject device’s plastic components, namely the tibial insert.

The EXACTECH Defendants initiated a partial recall on August 30, 2021 due to some lots of the devices being packaged improperly without an additional oxygen barrier layer. That recall was not publicly announced until December 4, 2021 and even then, the full extent of the impacted devices was not disclosed. 

Oxidation severely degrades the mechanical properties of the Ultra High Molecular Weight Polyethylene (UHMWP) plastic found in the tibial component leading to accelerated wear debris production, bone loss, component fatigue, cracking, and fracture, and the increased need for revision surgery.

This degradation can occur both on the shelf or after implantation in patients because oxygen exists in body fluids such as synovial fluid and blood.

Our clients received these recalled plastic components during both their original total knee replacement and revision surgeries.

About the Exactech knee replacement recall 

In their February 7, 2022, Dear Doctor letter, Exactech recalled many of their polyethylene liners manufactured in 2004 or later. The recall was issued by the FDA after confirming that non-conforming packaging increased the risk that polyethylene lines could degrade and fail early, which often led to bone loss and revision surgery for those with the implants. Experts estimate that nearly 150,000 people received a defective implant and are eligible to file suit against the company. [1]

According to the company, Exactech replacements are comprised of proprietary polyethylene materials. Defendants touted the Optetrak Logic system as being first-in-class, high-performing and having key benefits such as long-term implant survivorship.

For many years reports from the public and academic and clinical studies proved just the opposite – the devices had higher than expected revision rates and performed poorly when compared to its competitors. [2] Even more tellingly, The Australian Registry, a preeminent, internationally recognized resource for evaluating orthopedic implants, consistently identified the Exactech Optetrak PS Classic total knee system device as an implant with a higher-than-expected rate of revision.

The Australian Registry reported that every Exactech Optetrak Total Knee Replacement (“TKR”) polyethylene component combination demonstrated statistically significant increased revision rates compared to other TKR systems (N=668,852) with at least one and a half years of follow-up with hazard ratios ranging from 1.84 to 5.85 (p<0.001).

Nonetheless, the company did not issue any warnings to consumers nor take any corrective actions to improve the safety of their products. 

About the defect 

Polyethylene materials require special care to prevent oxidation prior to surgery because oxidation inhibits the device’s mechanical ability and significantly increases susceptibility to failure. At the time, Exactech used gamma-insert sterilization with barrier packaging to store their devices and minimize oxidation. However, gamma-inert sterilization creates highly-reactive molecules that are more likely to bond with oxygen, causing both oxidation and degradation of the device’s plastic components.

Eventually, these devices sustain pitting, delamination and fracturing which causes a breakdown of the device, foreign particles to enter the patient’s bloodstream, bone breakdown and then eventually device failure requiring revision or full replacement. 

Proper barrier packaging is needed to avoid exposure of the devices’ plastic components to oxygen while they are on the shelf. Here, Exactech failed to do exactly that.

In addition, we believe there were feasible alternative design and manufacturing options available to the Defendants to decrease or eliminate this oxidation process, which they failed to use in their devices. 

Recipients of the faulty implants are more likely to experience pain, swelling, or difficulty moving the joint as a result of the oxidized implant leading to bone loss. [3] In some cases, recipients must undergo additional revision surgeries to correct for the failure, but revision surgeries can be costly and physically intensive because they are more difficult to perform than primary joint replacements. 

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

  • OPTETRAK® All polyethylene Tibial Components
  • OPTETRAK® Tibial Inserts
  • OPTETRAK Logic® Tibial Inserts
  • TRULLANT® Tibial Inserts
  • VANTAGE® Fixed-Bearing Liner Component

Contact your surgeon and confirm your device’s serial number with Exactech’s recall page to see if you are eligible for compensation. 

Further, Exactech has also informed surgeons that recipients of the GXL hip implant may also be at risk for premature wear under certain conditions.

If you have received a GXL hip implant within the last six years, contact your surgeon to determine if there was wear or deterioration. 

Contact us today to learn more about the Exactech recall lawsuit process

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.

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

If you have received a recalled implant, contact the Jacob Fuchsberg Law Firm for a free Exactech recall lawsuit consultation.

We can help you file a product liability lawsuit for medical expenses incurred, additional surgeries, as well as any pain and suffering that you or your immediate family have experienced due to the faulty implant. 

Let our family help yours.

Resources

[1] Llamas, M. (2022, April 4). Exactech Replacements (S. Clifton, Ed.). DrugWatch. https://www.drugwatch.com/exactech-replacement/ 

[2] Thelu, C., Pasquier, G., & Migaud, H. (2012). Poor results of the Optetrak cemented posterior stabilized knee prosthesis after a mean 25-month follow-up: Analysis of 110 protheses, Orthopedics and Traumatology, 98(4), 413-420. https://doi.org/10.1016/j.otsr.2012.04.008  

[3] Anderson, A. (2022, May 25). Are You Affected by the Exactech Poly Implants Recall? Legal Reader. https://www.legalreader.com/are-you-affected-by-the-exactech-poly-implants-recall/