P.F.C. SIGMA 96-1043Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CRUCIATE SUBSTITUTING BOX TRIAL SZ 3 · Class 1
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy P.F.C. Sigma cruciate substituting box trial is a template used to test fit during knee replacement surgery. The 28 reports mostly describe worn or stripped screws, threads that no longer catch, and parts bending or twisting so the trial sticks or won't lock onto the femoral trial. In most cases surgery still went ahead, with only brief delays and no effect on the patient. There are 28 malfunction reports, no deaths and no injuries, and no recalls name this device.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295234715), received between Aug 11, 2017 and Dec 12, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (10 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
- Naturally Worn10
- Device-Device Incompatibility7
- Material Deformation7
- Material Twisted/Bent7
- Appropriate Device Problem Term/Code Not Available6
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions11
- No Information4
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CREW WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794423 ↗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 21425749 ↗MalfunctionJan 30, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE SIGMA SIZE 3 FEMORAL COMPONENT TEST BOX IS IN POOR CONDITION, IT DOES NOT THREAD THE SCREW. THE SURGERY WAS SUCCESSFULLY ACHIEVED, IT WAS USED WITHOUT ADJUSTMENT. IT DID NOT AFFECT THE PATIENT, THE SURGERY WAS DELAYED ABOUT 5 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18605140 ↗MalfunctionApr 5, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT TRIAL IS WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681986 ↗MalfunctionJan 31, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SCREW ON SIDE OF PS BOX TRIAL WON'T LOCK INTO FEMORAL TRIAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16272869 ↗MalfunctionJan 23, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT BOX TRIAL SET SCREW IS STRIPPED AND STUCK IN FEMUR TRIAL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16223566 ↗MalfunctionDec 7, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SIZE 3 BOX TRIAL IS STUCK ON FEMUR TRIAL. SCREWDRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15932177 ↗MalfunctionNov 17, 2022Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15818878 ↗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 15796806 ↗MalfunctionMar 14, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PRODUCT SCREW MECHANISM NOT WORKING. SCREW IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13756448 ↗MalfunctionJan 13, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT ITEM REPORTED AS DAMAGED AND NEEDS TO BE REPLACED. WORN GRUB SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13251512 ↗MalfunctionDec 22, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS NOTICED BY THE SCRUB TECH THAT THE BLACK HANDLE THAT IS USED TO TIGHTEN THE PS BOX ONTO THE FEMORAL COMPONENT HAD BEEN STRIPPED. THE DRIVER AND BOX BOTH ARE STRIPPED, BUT DID NOT BREAK INTO PIECES THEREFORE THE TWO INSTRUMENTS ARE IN FULL CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11057851 ↗MalfunctionAug 17, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW ON BOX TRIAL IS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10414265 ↗MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW ON THE BOX TRIAL WILL NO LONGER ENGAGE TO THE FEMUR. THERE WAS NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10398600 ↗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 9280995 ↗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 9280992 ↗MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent
THE SET SCREW IS STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9238842 ↗MalfunctionMay 23, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT THE SIGMA SIZE 3 LEFT PC FEMUR BOX IS CROSS THREADED AND STRIPPED INSIDE THE FEMUR AND WILL NOT COME APART. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637558 ↗MalfunctionFeb 4, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE SIZE 3 SIGMA BOX WOULD NOT UNSCREW FROM THE FEMORAL TRIAL. THE SCREW SEEMS TO BE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8300947 ↗MalfunctionOct 8, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREW ON THE SIDE OF THE BOX IS STRIPPED AND WILL NOT ALLOW YOU TO SCREW IN AND ATTACH TO THE FEMORAL TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7942448 ↗MalfunctionAug 28, 2018Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
THE INSTRUMENTS WERE BEING REPORTED FOR UNKNOWN REASON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7822452 ↗MalfunctionJul 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE BOX IS STRIPPED AND STUCK ON FEMUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7715827 ↗MalfunctionApr 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CS WAS UNABLE TO UNSCREW A SIZE 3 SIGMA PS BOX TRIAL OUT OF THE FEMORAL TRIAL. THE SET SCREW IS STRIPPED AND THEY ASKED FOR IT TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7446257 ↗MalfunctionNov 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SIZE 3 SIGMA PS TRIAL BOX SCREW WAS NOTICED BY SURGICAL TECH TO BE STRIPPED. ANOTHER FEMORAL TRAY WAS OPENED AND CASE NOT DELAYED.
Patient problems: No Information
MAUDE report 7006043 ↗
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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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