P.F.C. SIGMA 96-1362Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 4 12.5mm 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 10603295237389), received between Aug 15, 2018 and Oct 26, 2021 — 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
- Crack1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- No Code Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2021Break; Crack; Break; Crack
IT WAS REPORTED THAT THE BOTTOM EDGE OF TRIP THAT SITS INSIDE TIBIAL TRAY WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12698522 ↗MalfunctionMar 19, 2021Break; Break
IT WAS REPORTED THAT THE POLY INSERT CHIPPED DURING EXTRACTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11528453 ↗MalfunctionMar 15, 2021Break; Scratched Material; Break; Scratched Material
TWO OF THE HP PFC CURVED INSERTS HAVE BEEN DAMAGED THROUGH USE OVERTIME. A PIECE WAS BROKEN (CHIP) AND NOTHING WAS LEFT IN PATIENT. IT MAY HAVE OCCURRED IN THE CLEANING PROCESS AND THE SCRATCHES FROM REGULAR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11487836 ↗MalfunctionNov 12, 2020Break; Break
A PIECE OF A 4 12.5 CURVED FB TIBIAL INSERT TRIAL BROKE OFF DURING EXTRACTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10831413 ↗MalfunctionDec 4, 2018Break; Naturally Worn; Break; Naturally Worn
TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE.
Patient problems: No Code Available
MAUDE report 8128896 ↗MalfunctionSep 18, 2018Break; Break
IT WAS REPORTED THAT THE SIZE 4X12.5 CURVED INSERT TRIAL BROKE UPON REMOVAL. THE ANTERIOR LIP BROKE. ALL PIECES REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7886704 ↗MalfunctionAug 15, 2018Break; Break
IT WAS REPORTED THAT DURING EXTRACTION OF THE INSERT TRIAL, SURGEON USED A NARROW HOHMAN AND AN ANTERIOR PIECE OF THE TRIAL BROKE OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784224 ↗
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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