SIGMA 9505-02-042Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT TRAY TRIAL SZ 2.5 · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295227588), received between Aug 23, 2017 and Mar 29, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT A HEADED PIN THROUGH THE SIZE 2.5 SIGMA TIBIA BASEPLATE, IT WAS FOUND THAT THE PIN WOULD NOT GO THROUGH ONE OF THE HOLES. NO ADVERSE EVENTS OCCURRED AND THERE WAS NO DELAY IN SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637126 ↗MalfunctionAug 23, 2017Break; Break
IT WAS REPORTED THAT THE TIBIAL TRAY TRIAL BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED.
Patient problems: No Information
MAUDE report 6813489 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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