P.F.C. SIGMA 96-1044Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CRUCIATE SUBSTITUTING BOX TRIAL SZ 4 · Class 1
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy P.F.C. Sigma cruciate substituting trial box used during knee surgery to test implant fit before the real part goes in. The 47 reports mostly describe screws and parts stripping, rounding off, bending, or cold-welding so the box would not attach to or release from the femoral trial, and boxes not fitting the test femur. All47 reports are malfunctions with no deaths and no injuries, and none name a recall. Reports were far fewer in the last 12 months than the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295234722), received between Jun 28, 2017 and Feb 20, 2025 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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
- Device-Device Incompatibility17
- Material Twisted/Bent13
- Naturally Worn11
- Material Deformation8
- Appropriate Device Problem Term/Code Not Available7
- Detachment of Device or Device Component2
- Break1
- Device Issue1
Patient problems
- No Consequences Or Impact To Patient29
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information3
- No Information2
- Not Applicable2
- No Code Available1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREWDRIVER IS STRIPPED, NOTCH TRIAL SCREWS ARE STRIPPED .
Patient problems: Insufficient Information
MAUDE report 21425646 ↗MalfunctionNov 19, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEM DID NOT FIT IN THE TEST FEMUR. THE INSTRUMENT BOX NEEDS A SCREW AND IS LOOSE AT ONE END, WHICH CAN CAUSE LOSS OF MATERIAL.
Patient problems: Insufficient Information
MAUDE report 20722854 ↗MalfunctionNov 19, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEM DID NOT FIT IN THE TEST FEMUR. THE INSTRUMENT BOX NEEDS A SCREW AND IS LOOSE AT ONE END, WHICH CAN CAUSE LOSS OF MATERIAL.
Patient problems: Insufficient Information
MAUDE report 20722798 ↗MalfunctionMar 27, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SIZE 4 PS BOX SCREW WAS STRIPPED AND THE STAFF WERE UNABLE TO UNSCREW IT FROM THE SIZE 4 RIGHT FEMUR AT THE END OF THE CASE. THERE WAS NO DELAY OF CASE AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18987832 ↗MalfunctionMar 13, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SIZE 5 PS BOX SCREW WAS STRIPPED AND THE STAFF WERE UNABLE TO UNSCREW IT FROM THE SIZE 5 RIGHT FEMUR AT THE END OF THE CASE. NO DELAY OF CASE AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18893576 ↗MalfunctionSep 12, 2023Naturally Worn; Naturally Worn
THE GRUB SCREW THAT IS USED TO ATTACHED THE BOX TRIAL TO THE FEMORAL TRIAL HAS ¿ROUNDED OFF¿ SO ITS NOT POSSIBLE TO LOOSEN THE BOX TRIAL FROM THE FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17733738 ↗MalfunctionFeb 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NOTCH TRIAL IS STUCK ON FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16416875 ↗MalfunctionJan 6, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE SCREW WAS COLD WELDED. THE BOX WILL NO LONGER ATTACH TO FEMUR TRIALS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16111737 ↗MalfunctionNov 15, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE BOX TRIAL SCREW IS STRIPPED, CANNOT DISENGAGE FROM FEMUR TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15796829 ↗MalfunctionJul 19, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BOX WAS CROSS THREADED INTO A 4 LEFT SIGMA POSTERIOR STABILIZED FEMUR TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15051458 ↗MalfunctionJul 15, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SCREW HOLE FOR THE BOX TRIAL HAS BECOME ROUNDED OFF SO CANNOT BE REMOVED FROM THE FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15028608 ↗MalfunctionDec 2, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SZ4 FEMORAL PS BOX HAD STRIPPED OUT IN THE 4N LEFT FEMORAL TRIAL. IT COULD NOT BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12916914 ↗MalfunctionAug 10, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE FEMORAL TRIAL IS WORN. THERE WAS NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300129 ↗MalfunctionMay 14, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
FEMORAL BOX SET SCREW IS STRIPPED. FEMORAL BOX TRIAL WOULD NOT ATTACH TO FEMUR TRIAL. NO SURGERY DELAY. PROCEDURE SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826483 ↗MalfunctionNov 5, 2020Device-Device Incompatibility; Device-Device Incompatibility
AFTER THE CONFERENCE, THE FOLLOWING DIVERGENCES WERE DETECTED: THE SCREW IN QUESTION IS NOT HOLDING IN THE FEMUR TEST. PRODUCT: 961044, BATCH: NB68958. THE SCREW HEAD IS DAMAGED. PRODUCT: 961045, BATCH: SO2031909.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10792590 ↗MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVER TIP WAS STRIPPED. SZ 4 NOTCH TRIAL SCREW HEAD WAS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10730391 ↗MalfunctionOct 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
UPON INSTRUMENT INSPECTION PS BOX TRIAL WAS NOT ABLE TO BE DISENGAGED FROM THE FEMORAL TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10670820 ↗MalfunctionJul 31, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED STATED THAT THE THREAD OF THE SCREW OF THE TEST INTERCONDYLAR CASE WAS DAMAGED - LOCKED (WORN), SO IT DID NOT ALLOW MOVING FORWARD OR BACKWARD WHICH MADE IT IMPOSSIBLE TO ADAPT TO THE TEST FEMUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10349614 ↗MalfunctionJul 23, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED STATED THAT THE FEATURES THAT WERE WORN AND NOT MAKING THEIR FUNCTIONS AS INTENDED WERE THE RECESS IN THE SCREW FOR THE BOX TRIAL AND THE TIP OF THE SCREWDRIVER.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10315031 ↗MalfunctionJul 22, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SET SCREW IS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10308658 ↗MalfunctionJan 30, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT FEMORAL IMPACTOR PLASTIC BROKE OFF FROM ITS METAL BASE, IT IS BROKEN INTO TWO SEPARATE PARTS. SIZE 4 PS BOX TRIAL SCREW IS STRIPPED AND WILL NOT THREAD INTO THE SIZE 4 FEMORAL TRAIL.
Patient problems: Not Applicable
MAUDE report 9648066 ↗MalfunctionDec 12, 2019Material Twisted/Bent; Material Twisted/Bent
SIGMA BOX TRIAL STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9459887 ↗MalfunctionNov 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE FEM BOX SCREW STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9280987 ↗MalfunctionNov 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE FEM BOX SCREW STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9280985 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT WILL NOT HOLD FEMORAL TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9239773 ↗
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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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