SIGMA 9505-01-224Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE TIBIAL CUTTING BLOCK LT 3 DEG · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295225294), received between May 21, 2019 and Apr 28, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 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
- Material Deformation3
- Naturally Worn2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Material Integrity Problem
IT WAS REPORTED THAT SPD REQUESTED BLOCK BE REPLACED DO TO METAL BEING DAMAGED. NO DELAYS. THERE WAS NOTHING LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019229 ↗MalfunctionJun 15, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SIGMA CUTTING BLOCK IS SHOWING SIGNS OF WEAR AND TEAR: THE EDGES OF THE CUTTING SLOT ARE "BURRED" AND WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136614 ↗MalfunctionOct 11, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIBIAL CUTTING BLOCK SLOT HAS STARTED TO CAUSE METAL SPURS WHICH MAY BECOME SHARP OR BREAK OFF IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579588 ↗MalfunctionMay 21, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE 3 DEGREE LEFT TIBIAL CUTTING BLOCK WAS WORN ON THE MEDIAL ASPECT OF THE CUTTING SLOT AND A NEW INSTRUMENT IS NEEDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8629414 ↗
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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