P.F.C. SIGMA 96-1342Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CURVED 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295237143), received between Nov 29, 2018 and Jun 2, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Crack1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2022Break; Break
IT WAS REPORTED THAT THE PLASTIC ON THE POLY TRIALS PEELED WHILE DOING TRIAL REDUCTION. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14581698 ↗MalfunctionNov 10, 2020Break; Break
IT WAS REPORTED THAT THE BOTTOM PLASTIC EDGE FROM THE INSERT TRIAL BROKE OFF IN ONE PIECE. THE PIECE WAS FOUND AND REMOVED FROM PATIENT. NO LOT NUMBER OR PRODUCT NUMBER CAN BE DETECTED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10816742 ↗MalfunctionDec 17, 2019Break; Break
IT WAS REPORTED THAT THE THREE SIGMA TIBIAL INSERTS WERE PULLED FROM SETS BY CENTRAL SUPPLY BECAUSE THEY HAD CRACKS IN THEM. NO PIECES WERE MISSING. ALL THREE INSERTS ARE BEING RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9483180 ↗MalfunctionNov 30, 2018Crack; Crack
IT WAS REPORTED THAT THE 5X10 SIGMA CURVED INSERT TRIAL BROKE ALONG THE BOTTOM LIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8120118 ↗MalfunctionNov 29, 2018Naturally Worn; Naturally Worn
TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE, HOSPITAL ARE NOT PREPARED TO RE STERILISE.
Patient problems: No Code Available
MAUDE report 8117166 ↗
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