Cadence Total Ankle System 10204306Recalls & reported problems
Smith & Nephew, Inc. · CADENCE IMPLANT PROTECTOR - LEFT · Class 1
All models of Cadence Total Ankle System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556851777), received between Jul 20, 2023 and Nov 3, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT, DURING A TOTAL ANKLE SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - LEFT BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459673 ↗MalfunctionDec 3, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TAR SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - LEFT BROKE INTERNAL TO THE PATIENT'S ANATOMY. PIECES WERE RETRIEVED USING TWEEZERS. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20839035 ↗MalfunctionDec 3, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - LEFT 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 20833561 ↗MalfunctionMay 15, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING AN ANKLE REPLACEMENT, THE CORNER OF ONE (1) CADENCE IMPLANT PROTECTOR - LEFT BROKE AT JUNCTION WHERE END PIECE THREADS ONTO HANDLE. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19321340 ↗MalfunctionJul 20, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING IMPLANT INSERTION IN A TOTAL ANKLE ARTHROPLASTY, A CADENCE IMPLANT PROTECTOR - LEFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17368154 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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