P.F.C. SIGMA 96-1453Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 4 15mm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295238713), received between Dec 18, 2017 and Jun 4, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2021Break; Break
TODAY WHILST DOING KNEE SURGERY THE SURGEON REPORTED THE BREAKAGE OF THE IMPLANT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11940051 ↗MalfunctionJan 27, 2020Break; Break
IT WAS REPORTED THAT WHILE PUTTING IN THE SIGMA STABILIZED TIBIAL INSERT TRIAL SIZE 4 X 15MM, A PIECE OF THE INSERT BROKE OFF FROM THE INSERT TRIAL. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND DISCARDED. NO LOT NUMBER IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9635169 ↗MalfunctionNov 6, 2019Break; Break
IT WAS REPORTED THAT THE TRIAL POLY WAS CRACKED UPON INSERTING ONTO THE TIBIAL TRAY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287141 ↗MalfunctionApr 17, 2018Break; Break
DER STATES THAT WHILE TRIALING THE COMPONENTS, A RANGE OF MOTION WAS PERFORMED AND THE 4 X 15MM PS FB TRIAL INSERT BROKE ON THE BOTTOM OF THE TRIAL. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND SURGERY TIME WAS NOT DELAYED. LOT NUMBER IS UNAVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7435770 ↗MalfunctionDec 18, 2017Break; Break
DER STATES THAT THE SURGEON WENT TO REMOVE THE STABILIZED INSERT TRIAL AND A CRACK WAS FORMED IN THE INSERT TRIAL. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO LOT NUMBER WAS PRESENT/READABLE ON THE INSERT TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7125166 ↗
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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