Cadence™ 10203101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780356295), received between Jun 5, 2022 and Jun 16, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN ANKLE REPLACEMENT, BOTH CADENCE TIBIAL IMPACTOR TIPS (40 AND 45 DEGREES) WERE MISSING. ALTHOUGH REQUESTED, PRODUCTS WERE NOT SHIPPED OUT FROM THE WAREHOUSE. THE SURGERY TOOK OVER 1.5 HOUR MORE BECAUSE THE FLANGE COULD NOT BE PLACED CORRECTLY AND HAD TO REMOVE EVERYTHING. A POSTERIOR-MEDIAL INCISION UNDER ACHILLES HAD TO BE MADE TO PROPERLY PLACE THE TIBIAL IMPLANT. FINALLY, THE IMPLANTS WERE PLACED CORRECTLY.

  Patient problems: Perforation

  MAUDE report 14719532 ↗
• MalfunctionJun 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE PROCEDURE, THE GREEN TIP OF A CADENCE TIBIAL IMPACTOR TIP BROKE OFF, MAKING IT IMPOSSIBLE TO ATTACH IT TO THE TIBIAL COMPONENT. A DELAY OF 2 MINUTES WAS REPORTED TO OCCUR, AND THE SURGERY WAS RESUMED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO BROKEN PIECES ENTERED THE PATIENT. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599421 ↗