Cadence® 10203102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780417132), received between May 5, 2022 and Nov 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE REPLACEMENT SURGERY, ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874924 ↗
• MalfunctionJun 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A CADENCE 45 DEGREE TIBIAL IMPACTOR TIP IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14727542 ↗
• MalfunctionMay 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, TWO (2) 45 DEGREE TIBIAL IMPACTOR TIP ARE BROKEN. AS THIS WAS NOTICED DURING THE SET-UP OF A SURGERY, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288304 ↗