SIGMA 9505-02-156Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FIXED REFERENCE AP CHAMFER BLOCK 4 · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295228554), received between Jan 5, 2021 and Dec 11, 2023 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SAW BLADE WAS DIFFICULT TO PASS THROUGH CUTTING BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301282 ↗MalfunctionMay 3, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEMORAL PREP SET HAS SLIGHTLY DAMAGED CUTTING BLOCKS. SAW BLADE WON¿T GO THROUGH AS BEEN CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16861729 ↗MalfunctionJan 5, 2021Scratched Material; Scratched Material
CUTTING BLOCKS HAVE BEEN INSPECTED AND HOSPITAL NOT HAPPY TO LEAVE THE BLOCKS IN THEIR TRAYS IN THEIR CURRENT STATE. TOO MANY SCUFF MARKS AND SAW BLADE SCIVE MARKS WITH SOME SLIGHTLY SHARP METAL KNICKS IN MULTIPLE AREAS. PATIENT STATUS/ OUTCOME / CONSEQUENCES UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(6), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11119591 ↗
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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