P.F.C. SIGMA 96-1360Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CURVED 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
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295237341), received between Dec 6, 2017 and Sep 5, 2023 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient3
- No Information2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE.
Patient problems: Insufficient Information
MAUDE report 17681931 ↗MalfunctionNov 30, 2021Break; Break
IT WAS REPORTED THAT THE PART OF THE BOTTOM ON THE SZ 4 CVD SIGMA 8MM INSERT TRIAL BROKE OFF DURING SURGERY AND NEEDS TO BE REPLACED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12896124 ↗MalfunctionFeb 5, 2020Break; Break
IT WAS REPORTED THAT THE A SIGMA CURVED SIE 4, 8MM POLY TRIAL HAD A PART THAT WAS CHIPPED OFF ON THE BOTTOM. THE EDGE AROUND THE BOTTOM THAT LOCKS THE TRIAL IN WHICH THE TRIAL TRAY WAS CHIPPED OFF ON A SIDE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9672577 ↗MalfunctionJun 5, 2019Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE INTO 2 PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8672080 ↗MalfunctionDec 4, 2018Break; Naturally Worn; Break; Naturally Worn
TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE.
Patient problems: No Code Available
MAUDE report 8128859 ↗MalfunctionNov 19, 2018Break; Break
IT WAS REPORTED THAT THE SIGMA CURVED INSERT TRIAL WAS BROKEN DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8086837 ↗MalfunctionDec 6, 2017Break; Break
MalfunctionDec 6, 2017Break; Break
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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