Cadence Total Ankle System 10207113Recalls & reported problems
Smith & Nephew, Inc. · CADENCE TIBIAL TRAY. SIZE 3X. RIGHT · Class 2 · Implant
All models of Cadence Total Ankle System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556852354), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K151459); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Periprosthetic fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN ANKLE SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2018, THE CLINICAL SUBJECT EXPERIENCED A PERIPROSTHETIC FRACTURE AROUND INTERNAL PROSTHETIC RIGHT ANKLE ON (B)(6) 2018. THIS ADVERSE EVENT WAS SOLVED BY A SURGERY ON (B)(6) 2018 AND MEDICATION. THE CURRENT OUTCOME OF THE SUBJECT IS RECOVERED/RESOLVED.
Patient problems: Periprosthetic fracture
MAUDE report 25024674 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K151459. One submission often covers many models, so check the product and lot details in each record.
- Z-1192-2017 · Jan 20, 2017 · TerminatedIntegra Cadence Total Ankle System
- Z-2086-2016 · Apr 29, 2016 · TerminatedCadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- Vantage 350-21-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 reports
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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