Cadence™ 10204305Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780240778), received between Jun 17, 2022 and Nov 28, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, A PIECE OF THE CADENCE IMPLANT PROTECTOR - RIGHT BROKE FROM IMPACT WITH HAMMER WHILE APPLIED THE CADENCE INSERT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875014 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TAA, THE SURGEON FRACTURED THE CADENCE IMPLANT PROTECTOR - RIGHT WHILE IMPACTING THE TALUS. SURGEON NOTICED AFTER IMPACTION WAS COMPLETE; THEREFORE, THERE WAS NO SURGICAL DELAY. THE FRAGMENT WAS EASILY RETRIEVED FROM PATIENT BY HAND. NO SURGICAL DELAY OR HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15684098 ↗
• MalfunctionOct 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - RIGHT BROKE WHILE OUTSIDE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629297 ↗
• MalfunctionJul 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TAR SURGERY, THE CADENCE IMPLANT PROTECTOR - RIGHT BROKE WHEN PUTTING IN THE IMPLANT. IT IS UNKNOWN IF ANY PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911818 ↗
• 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 14727622 ↗