P.F.C. SIGMA 96-1432Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 2.5 12.5mm 67mm M/L 45mm A/P · Class 1
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295238287), received between Aug 31, 2017 and May 22, 2019 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
Patient problems
- No Consequences Or Impact To Patient4
- No Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2019Break; Break
INSTRUMENT BROKE INTO TWO PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8631588 ↗MalfunctionSep 14, 2018Break; Break
A PIECE OF THE PLASTIC BROKE OFF THE BACK OF THE INSERT TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7876289 ↗MalfunctionJun 14, 2018Break; Break
IT WAS REPORTED THAT A PIECE OF THE INSERT TRIAL BROKE OFF WHILE TRIALING. EVERYTHING WAS REMOVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7602855 ↗MalfunctionMar 6, 2018Break; Break
IT WAS REPORTED THAT THE TORQUE WRENCH DOESN¿T TURN THE SCREWDRIVER SHAFT, HUDSON ADAPTER STICKS ON THE REAMERS AND NEEDS TO BE REMOVED WITH MALLET AND PLASTIC BROKE ON 12.5 X 2.5 PS FIXED BEARING TRIAL - 2 PIECES. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7316958 ↗MalfunctionAug 31, 2017Break; Break
IT WAS REPORTED THAT THE BROKEN EDGES FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Information
MAUDE report 6835319 ↗MalfunctionAug 31, 2017Break; Break
IT WAS REPORTED THAT THE BROKEN EDGES FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Information
MAUDE report 6835296 ↗
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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