Cadence Total Ankle System 10204305Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556851760), received between Feb 28, 2023 and Feb 3, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE SURGERY, THE SURGEON SEATED THE TIBIAL IMPLANT AND USED ONE (1) CADENCE IMPLANT PROTECTOR - RIGHT WHEN SEATING THE TALAR IMPLANT WITH THE TALAR IMPACTOR. FORCE WAS DRIVEN THROUGH THE TALAR IMPACTOR TO CRACK THE CADENCE IMPLANT PROTECTOR - RIGHT IN TWO PIECES. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244994 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TOTAL ANKLE SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - RIGHT WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849843 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - RIGHT BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846618 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROPLASTY, A CADENCE IMPLANT PROTECTOR - RIGHT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836501 ↗
• MalfunctionMar 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL ANKLE REPLACEMENT SURGERY, THE SURGEON BROKE OFF A CADENCE IMPLANT PROTECTOR - RIGHT PROTECTOR WHILE REMOVING FROM IMPLANT. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT, BUT SURGERY WAS RESUMED WITHOUT ANY DELAY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926022 ↗
• MalfunctionMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL ANKLE SYSTEM SURGERY, THE HOLDER ON THE RIGHT SIDE OF THE CADENCE IMPLANT PROTECTOR - RIGHT BROKE OFF WHILE TRYING TO PLACE IT IN THE TIBIAL IMPLANT. FLOURO AND VISUALIZATION CONFIRMED THAT ALL PARTS WERE RETRIEVED AND ACCOUNTED FOR. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989227 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A CADENCE IMPLANT PROTECTOR - RIGHT WAS NOTICED TO BE BROKEN. 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 16645651 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL ANKLE REPLACEMENT SURGERY, THE CORNER OF A CADENCE IMPLANT PROTECTOR - RIGHT BROKE. BOTH PIECES WERE RETRIEVED WITHOUT NEGATIVE OUTCOME TO PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455798 ↗