Cadence Total Ankle System 10203101Recalls & reported problems
Smith & Nephew, Inc. · CADENCE TIBIAL IMPACTOR TIP · Class 1
All models of Cadence Total Ankle System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556851074), received between Jun 24, 2023 and Feb 18, 2026 — classified as 4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT, DURING A TAA, ONE (1) CADENCE TIBIAL IMPACTOR TIP CRACKED AND BROKE AFTER INSERTION WHILE SETTING IMPLANT IN PATIENT. GREEN PLASTIC DEBRIS WAS REMOVED FROM PATIENT INTRA OPERATIVELY. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377329 ↗MalfunctionJan 31, 2025Break; Break
IT WAS REPORTED THAT, DURING A TAR SURGERY, ONE (1) CADENCE TIBIAL IMPACTOR TIP BROKE. 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 21289011 ↗MalfunctionJun 14, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TAR SURGERY, ONE (1) CADENCE TIBIAL IMPACTOR TIP WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE BROKEN PIECES WERE RECOVERED BY THE SURGEON. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538451 ↗MalfunctionJun 24, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE PIECE OF GREEN PLASTIC IN ONE (1) CADENCE TIBIAL IMPACTOR TIP BROKE OFF OF THE IMPACTOR DURING IMPLANT IMPACTION. 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 17195881 ↗
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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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