SIGMA 9505-01-274Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE CLASSIC ROTATION GUIDE 3 DEG · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295225775), received between Nov 10, 2017 and Jan 28, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2019Break; Break
IT WAS REPORTED THAT THE DOCTOR WAS USING THE HEEL OF THE MALLET TO GET THE SIZING INSTRUMENT TO FIT FLASH AGAINST. WHEN HE TAPPED IT WITH THE MALLET THE PIECE SNAPPED IN HALF. BOTH PIECES WERE RETRIEVED. THERE WAS NO DELAY TO THE CASE SINCE WE HAD A EXTRA PIECE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8281190 ↗MalfunctionDec 4, 2017Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SIGMA FEMORAL SIZER ISN'T FUNCTIONING PROPERLY AND STICKING. THE SURGEON ASKED A REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7080241 ↗MalfunctionNov 10, 2017Break; Break
IT WAS REPORTED THAT THE HP CLASSIC ROT GDE 3DEG BROKE DURING A CADAVER LAB TRAINING.
Patient problems: No Information
MAUDE report 7017712 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page