P.F.C. SIGMA 96-1441Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 3 10mm 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
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295238454), received between Jul 13, 2017 and May 22, 2023 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (12 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
- Break12
- Crack1
- Device-Device Incompatibility1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions3
- No Information2
- Insufficient Information1
Recent adverse event reports
The 14 most recent of 14 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: Insufficient Information
MAUDE report 16973097 ↗MalfunctionMar 28, 2022Crack; Crack
IT WAS REPORTED THAT THE SIGMA FB POLY TRIAL CRACKED, SZ 3X 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13932498 ↗MalfunctionJan 27, 2022Break; Break
IT WAS REPORTED THAT THE HOSPITAL HAS ADVISED THAT DURING SURGERY TODAY THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366175 ↗MalfunctionJul 28, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PLASTIC RIM ON THE UNDERSIDE OF THE TRIAL HAD A PIECE BROKEN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240145 ↗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 9410469 ↗MalfunctionJul 24, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE TIBIA INSERT TRIAL IS WORN AND WILL NOT SIT IN TIBIA TRAY TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8823364 ↗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 8709633 ↗MalfunctionApr 2, 2019Break; Break
IT WAS REPORTED THAT THE INSERTS WERE BROKEN. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8474876 ↗MalfunctionAug 6, 2018Break; Break
IT WAS REPORTED THAT THE TRIAL INSERT BROKE WHEN IMPACTED. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7754213 ↗MalfunctionMay 29, 2018Break; Break
IT WAS REPORTED THAT THE SURGEON WAS TRAILING THE INSERT AND WHEN HE REMOVED THE TRIAL A PIECE OF THE INSERT TRIAL BROKE OFF AND LANDED ON THE MAYO TABLE. REP COULD NOT FIND ITEM AFTER CASE SO IT CANNOT BE RETURNED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7548529 ↗MalfunctionMay 7, 2018Break; Break
IT WAS REPORTED THAT THE STABILIZED S2 3X10 MILLIMETER INSERT TRIAL BROKE UPON INSERTION. ALL PIECES RECOVERED FROM PATIENT. NO SURGICAL DELAY NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7490171 ↗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 7310390 ↗MalfunctionJul 13, 2017Break; Break
IT WAS REPORTED THAT THE SIZE 3 10MM FB STABILIZED INSERT TRIAL CRACKED IN WASH. BROKEN PIECES TOSSED.
Patient problems: No Information
MAUDE report 6710076 ↗MalfunctionJul 13, 2017Break; Break
IT WAS REPORTED THAT THE SIZE 3 10MM FB STABILIZED INSERT TRIAL CRACKED IN WASH. BROKEN PIECES TOSSED.
Patient problems: No Information
MAUDE report 6710069 ↗
Other TEMPLATE devices
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- 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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