Exactech Total Ankle Replacement

In 2022, Exactech recalled thousands of polyethylene liners that are part of its Total Ankle Replacement implants. The Exactech ankle recall was related to defective packaging that was used for Exactech devices for nearly two decades. Patients experiencing complications are suing the company.

Last Modified: November 13, 2023
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How Do Exactech Total Ankle Replacements Work?

Exactech ankle replacement implant devices like the Vantage Total Ankle System work to stabilize the ankle and reduce severe ankle pain or the symptoms of ankle arthritis. Patients implanted with the device should experience more comfort doing daily activities or sports. Exactech ankle replacement devices are complex and use four components to mimic the ankle joint.

Key Facts
  • The devices require surgery to implant and a recovery period.
  • Each device comprises four components: The curved or flat cut talus, tibia, polyethylene liner and locking piece.
  • In 2022, Exactech issued a recall for the polyethylene liner component of the implant. The U.S. Food and Drug Administration updated it in 2023 to encompass other Exactech implants.

The 2022 recall of Exactech ankle replacement device components states that the polyethylene plastic liner was packaged incorrectly, leading to oxidation and degradation of the liner, which could lead to complications or a higher failure rate of the implant. The FDA updated the recall in March 2023 to include other Exactech replacement implants that also use polyethylene liners that may have had incorrect packaging.

Benefits and Risks of Exactech Total Ankle Replacements

Ankle replacement surgery using an Extactech implant can provide pain relief in patients who have severe arthritis or ankle pain. Previously the only solution for these patients would have been ankle fusion surgery, which decreases ankle mobility and makes movement more difficult. 

Ankle implant surgery, such as with an Exactech implant, doesn’t completely restore normal motion. It does allow patients to maintain some natural movement because the components of the implant mimic the components of the actual ankle joint. This can protect the other joints of the foot, provide pain relief and allow patients to participate in daily activities and even some sports.

Ankle Replacement Surgery Benefits
  • Improved quality of life
  • Increased joint function
  • Pain reduction
Ankle Replacement Surgery Risks
  • Infections
  • Loosening or wear of the implant
  • Nerve injury

Loosening of the artificial ankle joint may also occur slowly over time. Ankle replacements typically loosen earlier than hip or knee replacements and may last only five years. The risk of loosening increases with patients who are more active or overweight. Loosening eventually causes pain and often requires revision surgery to solve.

Exactech Ankle Recall

Exactech issued a voluntary recall of the polyethylene liners that were part of its Vantage Total Ankle System and Exactech knee replacement devices in 2022. However, the improper packaging impacted liners that were manufactured as early as 2004. The gap in dates between the manufacturing and official recall means that many patients received implants that came with improperly packaged liners.

Key Recall Updates
  • March 2023:
    The FDA issued a safety communication reminding patients and doctors of the recalled polyethylene liners, recommending that if a patient is experiencing any pain or issues with their replacement device, they should contact their health care provider right away.
  • April 2022:
    Exactech sent an Urgent Medical Device Correction Letter to surgeons, hospitals and health care professionals alerting them to potential polyethylene liner breakdown and damage due to improper packaging. The problem affected approximately 80% of liners manufactured since 2004.
  • February 2022:
    Exactech issued an urgent recall of the polyethylene liners packaged with its Vantage Total Ankle System. The recall affected more than 2,000 liners.

The Exactech ankle replacement recalls covered improperly packaged liners that could break down more easily inside the body and impact the effectiveness of the implant surgery. The recalled liners were exposed to more oxygen than they should have been and that exposure caused oxidation and degradation of the polyethylene. 

In 2021, the company issued a recall of the polyethylene liners that came with some of its Exactech hip replacement devices. The recall covered liners that had premature wear, but the exact cause is undetermined. Exactech knee replacement devices have also been recalled.

Exactech Ankle Lawsuits

Patients who received an Exactech ankle replacement and experienced adverse effects are filing Exactech replacement lawsuits. Some complications named in lawsuits include new or worsening ankle swelling, pain while walking, inability to bear weight, grinding or other noise, instability sooner than expected and required removal of their device. 

The similar nature of the complaints about Exactech ankle replacements led to the consolidation of cases concerning Exactech ankle, knee and hip replacement devices into multidistrict litigation. As of October 2023, the combined number of cases in the Exactech MDL #3044 reached 842. These cases are still pending, and Exactech has not offered a settlement nor have lawyers taken the company to court for trial.

What Should I Do if I Have an Exactech Total Ankle Replacement?

If you’ve received an Exactech Total Ankle Replacement device, speak to your doctor for further instructions. They may recommend monitoring your implant site and ask that you report any new or worsening symptoms right away. If you’re experiencing pain, swelling, joint instability or grinding, your doctor may recommend removal of the device.

To determine whether your implant is part of the Exactech recall, you must know the serial number of the device used in the procedure. You or your doctor can contact the surgeon who implanted the device to request this information. If you discover you have an Exactech Total Ankle Replacement that the recall covers, you should speak with an attorney experienced in medical device litigation for more information.

Please seek the advice of a medical professional before making health care decisions.