Exactech Recall

Exactech recently announced a recall for nearly 150,000 Optetrak and Connexion GXL liners used during knee, hip, and ankle replacements since 2004. According to the company, these polyethylene inserts are prone to premature wear and early failure.

Unfortunately, by the time the Exactech recalls were announced, tens of thousands of people had received these defective liners during joint replacement surgeries involving Exactech hip, knee, and ankle systems.

Exactech Lawsuit Investigation

Individuals who experienced complications after receiving an Exactech Optetrak or Connexion GXL polyethylene liner may be entitled to compensation for damages related to their injuries, including medical bills, lost wages, pain and suffering, and more. To learn more about your legal options for filing an Exactech lawsuit, please contact our office today by calling (888) 994-5118.

Exactech Connexion GXL Hip Replacement Liner Recall

In June 2021, Exactech announced it was recalling nearly 90,000 Connexion GXL acetabular liners after data suggested that some patients were experiencing premature liner wear within 3-to-6 months of hip replacement surgery. In a percentage of these cases, the liner wear led to femoral and acetabular osteolysis.

The Connexion GXL liners were used in conjunction with the following Exactech metal-on-plastic hip replacement systems:

  • Acumatch GXL
  • Novation GXL
  • MCS Hip System

Early wear of the Connexion GXL liner can lead to severe complications such as osteolysis (bone degeneration), component loosening, tissue and muscle damage, and weakening or loosening of the hip implant. Symptoms of implant failure and related complications may include

  • Hip pain
  • Stiffness
  • Limited range of motion/mobility
  • Difficulty walking

Ideally, a plastic-on-metal hip replacement will last 25 years or more. However, recipients of a recalled Connexion GXL liner may require revision surgery to remove and replace their Exactech hip implant within just a few years of their initial joint replacement surgery.

Exactech Optetrak Knee and Ankle Liner Recall

Months later, in February 2022, the company recalled 147,000 Optetrak Polyethylene liners used in knee and ankle replacements, including:

  • 60,926 Exactech Optetrak knee replacement lines used since 2004
  • 60,518 Exactech Optetrak Logic knee replacement liners used since 2009
  • 24,727 Exactech Optetrak Truliant knee replacement liners used since 2017

The same recall also included 1,561 Exactech Vantage liners used in ankle replacement surgeries since 2016.

According to Exactech, the Optetrak knee and ankle recalls were necessary because defective bags used to store the liners could allow oxygen to diffuse the plastic insert, resulting in oxidation prior to joint replacement surgery. This places patients at risk for:

  • Degrading Exactech plastic insert
  • Accelerated knee wear debris after implant
  • Bone loss, loosening, lysis, and pain after a knee or ankle replacement
  • Component fatigue, cracking, or fracture
  • Premature knee revision surgery

Symptoms of a defective liner may include:

  • New or worsening pain
  • Inability to bear weight or difficulty walking
  • Grinding, clicking, or other noise from the implant
  • Swelling
  • Instability

Patients with a defective Optetrak liner may require revision surgery to remove and replace their artificial joint. However, their doctors may also consider an isolated polyethylene insert exchange. Exactech is providing new plastic knee and ankle inserts that, according to the company, are properly packaged in conforming vacuum bags that will avoid future problems with premature wear and failure.

Should I Participate in the Exactech Broadspire Claims Process?

Exactech has already hired Broadspire, a settlement adjusting company, to oversee a claims reimbursement process related to its hip, knee, and ankle liner recalls. However, it appears eligible patients will only be compensated for “recall-related out-of-pocket expenses” through this program. It’s also unclear what rights individuals may give up by filing an Exactech recall claim with Broadspire.

Before filing an Exactech Broadspire claim, it’s essential to understand that, in addition to recall-related out-of-pocket expenses, victims of the Exactech recall may also be entitled to compensation for:

  • Pain and suffering caused by the failed implant;
  • Inconvenience and recovery time from additional surgery;
  • Lost wages or loss of earning capacity;
  • Past and future medical expenses that may directly result from the defective implants.

Participating in the Exactech claims program may require you to surrender all rights to any additional compensation. There’s also the possibility that any information you provide to Broadspire could be used to minimize any settlement you are entitled to receive.

For that reason, it’s in your best interest NOT to contact Exactech or Broadspire directly until you’ve had a chance to speak with an experienced medical device lawyer about your case.

Arrange for Your Free Exactech Lawsuit Review

Bernstein Liebhard LLP is offering free legal reviews to patients who experienced premature failure, osteolysis, and other debilitating complications allegedly related to the Exactech hip, ankle, and knee recalls. If you would like to explore your legal rights and options, please fill out the form on this page or contact our office directly at (888) 994-5118 to arrange for your free, no-obligation Exactech lawsuit review.

  1. FDA (June 2021) “Class 2 Device Recall Exactech Connexion” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=188093
  2. The Journal of Arthroplasty (May 2020) “Early Polyethylene Failure in a Modern Total Hip Prosthesis: A Note of Caution.” https://www.sciencedirect.com/science/article/abs/pii/S0883540319311921
  3. Exactech (February 2022) “US Exactech Recall Information” https://www.exac.com/medical-professionals/recall-information/
Last Modified: March 28, 2022

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