P.F.C. SIGMA 96-1015Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CRUCIATE RETAINING FEMORAL TRIAL - NON POROUS SZ 5 RT 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
- 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 10603295234661), received between Mar 29, 2019 and Aug 5, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Deformation2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2021Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation
IT WAS REPORTED THAT THE BARB ON THE LUG HOLE CAUSED METAL DEBRIS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12280002 ↗MalfunctionJan 13, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SIGMA FEMORAL TRIAL AND BOX. BOX IS STRIPPED AND WON'T COME OUT. ATTUNE TIBIAL IMPACTOR BROKE. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11164237 ↗MalfunctionNov 6, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SIZE 5 BOX TRIAL SEEMS BENT AND WILL NOT CONNECT TO THE SIZE 5 FEMUR TRIAL. BOTH PARTS BEING RETURNED. NO TIME ADDED TO CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287704 ↗MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9239436 ↗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 8463782 ↗
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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