P.F.C. SIGMA 96-1431Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 2.5 10mm 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295238263), received between Oct 6, 2017 and Jan 17, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Break; Break
DURING THE PROCEDURE FOR PLACING THE 2.5*10 TRIAL INSERT, A LOWER PART OF IT BROKE. THIS DID NOT AFFECT THE PATIENT OR THE SURGICAL PROCEDURE BECAUSE THE INSERT WORKED WELL AS A TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179181 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973069 ↗MalfunctionApr 28, 2023Break; Break
IT WAS REPORTED THAT AT THE TIME OF COMPONENT TESTING, SPECIALIST REMOVES TEST INSERT AND THE TEST INSERT BREAKS WITH NEGATIVE IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16832819 ↗MalfunctionMar 16, 2023Break; Break
IT WAS REPORTED THAT THE INSERT TRIAL BROKE; ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16561114 ↗MalfunctionNov 7, 2022Break; Break
IT WAS REPORTED THAT THE INSERT WOULD NOT FULLY ENGAGE IN TIBIAL TRAY OPENED A NEW ONE AND IT ENGAGED - BROKEN WHITE LEGO - BROKEN TIBIAL INSERT TRIAL. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN KNEE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749609 ↗MalfunctionMar 22, 2018Break; Break
IT WAS REPORTED THAT 2.5 X 8, 10 MM INSERT TRIALS BROKE. LIP THAT SITS IN TRAY ON BOTH. ALL PIECES RETRIEVED. SURGERY NOT DELAYED. TRIALS THROWN AWAY BY CPD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7362205 ↗MalfunctionOct 6, 2017Break; Break
IT WAS REPORTED THAT THE 10 MM FOR A 2.5 STABILIZED INSERT TRIAL BROKE DURING REMOVAL.
Patient problems: No Information
MAUDE report 6921949 ↗
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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