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Recent Publication Says Cartiva Toe Implant Failure Rate Higher Than Initially Reported

  • March 4, 2024
  • KBA_Whitney
  • No Comments

 

In seeking FDA approval, the authors of the MOTION study touted a Cartiva failure rate of less than 10%. However, a recent publication cites a much higher Cartiva failure rate. The paper, which was published in The Cureus Journal of Medical Science in November 2023, performed a retrospective cohort review of Cartiva implant procedures from 2016 to 2022 and  found “[a]t the final follow-up, 55% were still experiencing pain, 15% neurovascular symptoms, 10% swelling, and 50% stiffness or reduced range of movement.” The total re-operation rates were 17.4%, almost double the failure rates the makers of Cartiva reported to the FDA when seeking its approval.

Subsidence the Main Cause of Failures

The paper cites the reasons for revision as implant subsidence and reduced joint space due to implant degeneration. In fact, the authors found that a report “on the MAUDE database found the most common cause for adverse events related to Cartiva was subsidence.” Other publications have also uncovered higher rates of treatment, revision, and re-operation than the manufacturers initially reported.

Failed Cartiva Patients May Be Able to Recover Compensation

Many Cartiva patients are finding that the implant does not allow them to regain the pain-free active lifestyle that was marketed. Instead, they are being faced with injections, physical therapy, medical bills, and down time associated with a Cartiva revision or removal surgery. In fact, recovering from a failed Cartiva can take several months.

Signs and symptoms a Cartiva may be failing include:

  • Implant subsidence or slippage
  • Pain
  • Limited mobility
  • Limited range of motion
  • Gait affect, such as limping or favoring the other leg
  • Removal of the Cartiva or revision surgery

 

If you believe that you may have a failed Cartiva, contact KBA today at 855-KBA-LAWS (855-522-5297). There is no cost to speak with one of our attorneys to see what we can do to help.