P.F.C. SIGMA 96-1442Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 3 12.5mm 71mm M/L 47mm 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 10603295238485), received between Mar 2, 2018 and May 22, 2023 — 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.
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973155 ↗MalfunctionJan 18, 2022Break; Break
DURING SURGERY THE FOLLOWING TIBIAL INSERT TRIAL BROKE ON ITS DISTAL SURFACE. THE BROKEN PIECE WAS RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13283024 ↗MalfunctionDec 16, 2021Break; Break
IT WAS REPORTED THAT THE HOSPITAL HAS REPORTED 2 INSERT TRIALS AS BEING CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13020314 ↗MalfunctionOct 1, 2021Break; Break
IT WAS REPORTED THAT THE IMPLANT IS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12561184 ↗MalfunctionDec 10, 2020Break; Break
PART OF THE PLASTIC RIM OF THE TRIAL INSERT BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10984954 ↗MalfunctionJun 18, 2019Break; Break
IT WAS REPORTED THAT THE BOTTOM TIP OF THE TWO INSERT TRIALS BROKE OFF INTO SEPARATE PIECES. ALL PIECES RETRIEVED AND NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8709634 ↗MalfunctionMar 2, 2018Break; Break
IT WAS REPORTED ALL 3 OF THE TRIALS WERE FOUND TO BE DAMAGED UPON INSPECTION IN CENTRAL STERILE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7310346 ↗
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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