P.F.C. SIGMA 96-1340Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 2.5 8mm 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 10603295237105), received between Nov 29, 2018 and Dec 21, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Not Applicable1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2022Break; Naturally Worn; Break; Naturally Worn
INSTRUMENT HAS BROKEN DUE TO FAIR WEAR AND TEAR. SURGERY WAS NOT HELD UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16023100 ↗MalfunctionDec 9, 2022Break; Break
IT WAS REPORTED THAT THE SIGMA CURVED TIBIAL INSERT TRIAL SIZE 2.5 8 MM HAS A PART OF ITS PLASTIC LIP ABOUT TO BREAK OFF. THIS WAS POINTED OUT BY THE SCRUB TECH DURING THE SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949834 ↗MalfunctionOct 21, 2021Break; Break
IT WAS REPORTED THAT THE INSERT WAS CHIPPED IN SEVERAL PLACES, CAUSING A FEW SHARP EDGES TO FORM. THERE WAS NO SURGICAL DELAY AS THE INSTRUMENT WAS NOT USED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12675169 ↗MalfunctionOct 22, 2020Break; Break
IT WAS REPORTED THAT THE PFCSIG INS TRL CURVD LOCKING TABS WERE BROKEN OFF. THE SP2 TIBIAL RADEL IMPACTOR WAS CHIPPED. ALL PIECES WERE RETRIEVED AND ACCOUNTED FOR. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10717990 ↗MalfunctionJun 17, 2019Break; Break
IT WAS REPORTED THE SIGMA SZ 2.5 8 MM FB CVD INSERT TRIALS HAVE BROKEN. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8703714 ↗MalfunctionNov 29, 2018Naturally Worn; Naturally Worn
TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE, HOSPITAL ARE NOT PREPARED TO RE STERILISE.
Patient problems: Not Applicable
MAUDE report 8117150 ↗
Other TEMPLATE devices
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- 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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