SIGMA 9505-02-153Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FIXED REFERENCE AP CHAMFER BLOCK 2 · 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 10603295228523), received between Aug 16, 2017 and Nov 2, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
- Difficult to Remove1
- Inadequacy of Device Shape and/or Size1
- Incorrect Measurement1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2023Naturally Worn; Naturally Worn
NO ADVERSE EFFECT TO PATIENTS AND NO TIME ADDED ON TO PROCEDURE. DAMAGED PFC SIZE 2 CUTTING BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18054449 ↗MalfunctionApr 19, 2018Difficult to Remove; Difficult to Remove
DR (B)(6) - (B)(6) HOSPITAL (B)(6) 2018. SURGEON PINNED THE BLOCK INSITU, MADE THE FEMORAL CUTS BUT WHEN HE WENT TO BACK THE PINS OUT FROM THE BLOCK THE PIN WAS STUCK. ONCE JNJ REPRESENTATIVE GOT THE PIN OUT OF THE BLOCK IN CSSD, JNJ REPRESENTATIVE TRIED TO RUN ANOTHER PIN THROUGH THE BLOCK AND IT WAS VERY DIFFICULT TO SLIDE A PIN THROUGH THE ANGLED PIN HOLE ON THE RIGHT SIDE OF THE BLOCK. FEMALE PATIENT INITIAL: (B)(6). NO DELAY TO PROCEDURE. NO AE TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7442713 ↗MalfunctionAug 16, 2017Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE SIZE 2 CUTTING BLOCK SEEMED TO TAKE MORE BONE THAN REQUIRED FOR THE FEMUR. PATIENT HAS HEALTHY BONE QUALITY SURGEON WOULD LIKE DIMENSIONS MEASURED TO SEE IF THEY ARE CORRECT.
Patient problems: No Information
MAUDE report 6798759 ↗
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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