SIGMA 2024-99-007Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE-FEMORAL DISTAL CUT BLOCK · Class 1
All models of SIGMA (380)
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 10603295084167), received between Jan 7, 2020 and Sep 27, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 Incompatibility4
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FIXATION PIN GOT STUCK IN HOLE OF THE DISTAL CUTTING BLOCK. CAN'T GET IT OUT. NEED NEW CUTTING BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17825247 ↗MalfunctionMar 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SHIMS DIDN¿T FIT INTO THE NEW DISTAL CUTTING BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13901010 ↗MalfunctionMar 15, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE INSTRUMENTS ARE WORN AND NO LONGER FIT TOGETHER CORRECTLY. ANOTHER SET WAS OPENED AND USED TO FINISH THE CASE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13765422 ↗MalfunctionAug 9, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN GOT STUCK IN THE DISTAL CUTTING BLOCK. UNABLE TO REMOVE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12294989 ↗MalfunctionJan 7, 2020Material Twisted/Bent; Material Twisted/Bent
THE DISTAL FEMORAL CUTTING BLOCK FOR THE UNI SYSTEM IS WORN. THE CUTTING SLOT OPENING IS WORN ALLOWING THE BLADE TO OVER RESECT AND ALLOW MORE EXCURSION OF THE SAW BLADE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9558490 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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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