P.F.C. SIGMA 96-1450Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 4 8mm 76mm M/L 51mm 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 10603295238652), received between Dec 4, 2019 and Mar 25, 2024 — 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
- Crack1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED.A. DID IT BREAK INTO TWO OR MORE PIECES? IF YES, WERE ALL THE FRAGMENTS RETRIEVED FROM THE PATIENT? YES, ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970546 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973215 ↗MalfunctionJun 16, 2022Break; Break
TIBIAL TRIAL INSERT IS BROKEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14717393 ↗MalfunctionApr 29, 2022Break; Crack; Naturally Worn; Break; Crack; Naturally Worn
INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14250243 ↗MalfunctionJul 28, 2021Break; Break
IT WAS REPORTED THAT THE ATTUNE FEMORAL IMPACTOR WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240201 ↗MalfunctionJul 14, 2021Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12166711 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT THE 2 TIBIAL INSERT TRIALS WAS BROKEN DURING CASE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9410413 ↗
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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