P.F.C. SIGMA 96-1005Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CRUCIATE RETAINING FEMORAL TRIAL - NON POROUS SZ 5 LT 73mm M/L 69mm 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295234593), received between Sep 26, 2017 and Jun 4, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Naturally Worn2
- Appropriate Device Problem Term/Code Not Available1
- Corroded1
- Crack1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BOX WAS STRIPPED OUT INSIDE THE FEMORAL TRIAL.
Patient problems: Insufficient Information
MAUDE report 19463801 ↗MalfunctionJan 5, 2022Break; Corroded; Break; Corroded
IT WAS REPORTED THAT THE LUG HOLE IN FEMUR IS BURNISHED AND CAUSED LUG DRILL TO BIND. KEEL PUNCH WOULD NOT STAY ON HANDLE. NO BROKEN PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169739 ↗MalfunctionMar 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER´S CSSD IS COMPLAINING THE TRIALS NOT TO BE MARKED/ETCHED WITH AN ARTICLE NUMBER/REF NUMBER. SO IT IS NOT POSSIBLE TO IDENTIFY/CATEGORISE THE MEDICAL DEVICE. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8463771 ↗MalfunctionOct 24, 2018Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT LEFT SIGMA SZ5 BOX TRIAL SCREW IS STRIPPED AND UNABLE TO REMOVE FROM FEMUR TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8000665 ↗MalfunctionOct 24, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TRIAL HAS BEEN WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8000463 ↗MalfunctionSep 26, 2017Break; Crack; Break; Crack
IT WAS REPORTED THAT SIGMA CR FEMUR TRIAL CRACKED INSIDE DISTAL COMPONENT WHERE EXTRACTOR CONNECTS. METAL PIECES FELL OFF.
Patient problems: No Information
MAUDE report 6894654 ↗
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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