Answering Your Questions About the Exactech Knee Recall Lawsuit

Within the last year, global medical device manufacturer Exactech has recalled five joint replacement devices that show the potential to cause severe pain and injury to the patients who use them, sometimes even necessitating arduous revision surgery. Three of those devices are knee devices, more than 140,000 of which have been sold since 2004. If you have experienced pain or other complications from a recalled Exactech knee implant, you may have a right to compensation. Here’s what you need to know.

In February 2022, Exactech recalled several of its knee implant systems, including Optetrak, Optetrak Logic (pictured here), and Truliant.

Which Exactech Knee Devices Are Included in the Recall?

In August 2021, Exactech recalled knee replacements with a remaining shelf life of at least five years as of August 31, 2022. In February 2022, Exactech expanded on that recall, including three knee products regardless of the remaining shelf life. The recall involves the following knee replacement devices:

  • Exactech Optetrak implants (60,926 sold since 2004)
  • Exactech Optetrak Logic implants (60,518 sold since 2009)
  • Exactech Truliant implants (24,727 sold since 2017)

 

 

Why Were These Knee Devices Recalled?

A defective polyethylene tibial insert prompted the recall. In its “Urgent Medical Device Correction” letter to healthcare professionals on February 7, 2022, Exactech acknowledged that “most of our inserts manufactured since 2004 were packaged in out-of-specification vacuum bags.”[2] These vacuum bags are important because, according to Exactech's "Design Rationale," the inserts are placed in vaccuum bags to prevent oxidation, or exposure to oxygen. Oxidation resistance is an important safety consideration because the presence of excess oxygen can cause polyethylene to degrade, which can, in turn, cause patients to suffer severe pain, bone loss, and possibly infection.

 

 

The Importance of Cross-Linking in Joint Replacements

To help prevent oxidation and degradation, manufacturers employ a process called “cross-linking.” Importantly, highly cross-linked polyethylene is shown to be resistant to oxidation and wear. Exactech’s tibial inserts have limited cross-linking because a high level of cross-linking was “not necessary.” Exactech explicitly promoted the wear resistance and longevity of its knee replacement devices.[2] Although the recalled knee replacement implant devices have contained a defective tibial insert component since as early as 2004, Exactech took no action until their initial August 2021 recall.

Degraded polyethylene tibial inserts The photos above show degraded tibial inserts that required revision surgery.

How Do I Know If I Have An Exactech Knee Implant? If you are unsure whether your implant was one of the recalled Exactech devices, you can confirm by reviewing your medical records or contacting your orthopedic surgeon.

What Does This Mean for Patients with Recalled Knee Implants?

The accelerated breakdown of the tibial component may create harmful debris around the device and lead to severe pain and discomfort, bone loss and instability, infection, and injury. Patients may also need to undergo painful revision surgery. While the U.S. does not keep a joint replacement record, the Joint Replacement Registries of the United Kingdom, Australia, and New Zealand all report “statistically significant higher overall revision rates” for the Exactech Optetrak knee system compared to all other knee replacement implants.[1] Revision data was not reported for the Optetrak Logic or Truliant implants, but we know these devices contained the same defective tibial insert as the Optetrak implant.

What Are the Symptoms of a Failed Knee Implant?

If you or a loved one have experienced any of the following symptoms after receiving a recalled Exactech knee implant, you may have a right to compensation:

  • Osteolysis (bone tissue degeneration)
  • Revision surgery required
  • Pain around the implanted device
  • Limited mobility
  • Stiffness in the affected joint
  • Loosening of device components
  • Dislocation
  • Tibial loosening
  • Inflammation
  • Infection
  • Clicking/Popping of Joint

Pope McGlamry Specializes in Defective Orthopedic Device Lawsuits

When medical device manufacturers fail to create safe products, patient and their loved ones suffer. That’s why Pope McGlamry has represented thousands of clients in defective implant lawsuits. Our attorneys have been litigating against defective orthopedic device manufacturers, such as Stryker and Wright Medical, for over a decade. We have already filed a suit against Exactech on behalf of clients who received a defective hip implant. Call us today at (404) 523-7706 or fill out the form below for a free case evaluation.

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