Cadence Total Ankle System 10207102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556852293), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K151459); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL ANKLE ARTHROPLASTY SURGERY (RIGHT) WHICH HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED, ON (B)(6) 2022, ANTEROMEDIAL IMPINGEMENT SYNDROME, WITH ONGOING PAIN OF THE ANTERO- AND POSTMEDIAL RIGHT ANKLE, AND ADDITIONAL ADHERENCES OF THE TIBIALIS POSTERIOR TENDON. THIS ADVERSE EVENT WAS TREATED WITH AN ARTHROSCOPY OF THE RIGHT ANKLE AND A ADHESIOLYSIS OF THE TIBIALIS POSTERIOR TENDON, WHICH WERE CARRIED OUT ON (B)(6) 2022. AS A RESULT OF THIS TREATMENT, THE ADVERSE EVENT WAS REPORTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023. THERE WAS A PREVIOUS INCIDENCE OF ANTEROMEDIAL IMPINGEMENT SYNDROME THAT THE PATIENT HAD EXPERIENCED ON (B)(6) 2018. THIS WAS RESOLVED VIA ARTHROSCOPY AND CONSIDERED UNRELATED TO THE SECOND ADVERSE EVENT BY THE HCP, DOCUMENTED AS RESOLVED ON (B)(6) 2019.

  Patient problems: Joint Impingement

  MAUDE report 16764232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151459. One submission often covers many models, so check the product and lot details in each record.

• Z-1192-2017 · Jan 20, 2017 · Terminated
  Integra Cadence Total Ankle System
• Z-2086-2016 · Apr 29, 2016 · Terminated
  Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and