Cadence Total Ankle System 10203098Recalls & reported problems
Smith & Nephew, Inc. · CADENCE TALAR IMPACTOR · 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 00885556851067), received between May 15, 2024 and Jul 30, 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.
MalfunctionJul 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING ANKLE SURGERY, THE STEM BROKE OFF OF THE CADENCE TALAR IMPACTOR. 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 22670737 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT, DURING A TAR SURGERY, ONE (1) CADENCE TALAR IMPACTOR WAS HIT SO HARD THAT THE TIP BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR'S DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337365 ↗MalfunctionApr 20, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TAR SURGERY, ONE (1) CADENCE TALAR IMPACTOR CRACKED WHILE IMPACTING THE FINAL IMPLANTS, RESULTING IN SEPARATION OF PIECES. NO FRAGMENTS ENTERED THE SURGICAL SITE, AND ALL PIECES WERE ACCOUNTED FOR. THE IMPLANT WAS ALREADY FULLY IMPLANTED WHEN THE INCIDENT OCCURRED. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL 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 21870422 ↗MalfunctionFeb 5, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TAR PROCEDURE, A CADENCE TALAR IMPACTOR BROKE IN TWO. THE PROCEDURE WAS COMPLETED, 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 21317876 ↗MalfunctionMay 15, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, THE PROTECTOR OF ONE (1) CADENCE TALAR IMPACTOR 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 (AS IMPLANT WAS IN PLACE). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19321468 ↗
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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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