SIGMA 2024-40-100Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE TIBIAL CUTTING BLOCK LM/RL · Class 1
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy SIGMA HP partial knee tibial cutting block is a surgical guide used to make precise bone cuts during knee replacement. The 43 reports mostly describe wear and tear on the instrument: bent or broken blocks and chisels, damaged cutting slots that a saw blade cannot pass through, and parts that no longer fit together. None of the reports mention deaths or injuries, and most note no effect on the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295082972), received between Aug 18, 2017 and Apr 1, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (15 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn15
- Device-Device Incompatibility11
- Material Deformation10
- Break5
- Material Twisted/Bent4
- Scratched Material4
- Mechanical Jam3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient14
- Insufficient Information3
- No Information3
- No Code Available1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED: 1. DID IT BROKE INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, WORN OR CROSS THREADED? - NO. THE PIN WAS CROSS THREADED IN THE PIN HOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756217 ↗MalfunctionMay 14, 2025Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? THIS DID NOT HAPPEN DURING THE PROCEDURE SO NOT APPLICABLE. B. PLEASE VERIFY IF THERE WAS ANY ADVERSE EVENT/PATIENT HARM INVOLVED? THIS DID NOT HAPPEN DURING THE PROCEDURE SO NOT APPLICABLE. C. WHAT DO YOU MEAN BY DAMAGED FOR THE PRODUCT CODES: 202440100 AND 202440200? 202440100 - (B)(4) / (10) (B)(6) - SIGMA HP UNI TIB CUT BLK LM/R / (10) (B)(6) - SIGMA HP UNI TIB CUT BLK LM/RL ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL 202440100 - (B)(4) / (10) (B)(6) - SIGMA HP UNI TIB CUT BLK LM/RL ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL 202440200 - (B)(4) / (10) (B)(6) - SIGMA HP UNI TIB CUT BLK RM/LL - CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL ALL ITEMS ABOVE HAVE A CUTTING SLOT ¿ WHERE THE SAW BLADE HAS REPEATEDLY HIT THIS DURING SURGERY IT HAD WARPED THE METAL CAUSING DAMAGE AND THE SAW BLADE NO LONGER CAN FIT THROUGH THE CUTTING SLOT. ALL ITEMS ARE STILL IN ONE PIECE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22018346 ↗MalfunctionMay 14, 2025Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT THE ITEMS WERE DAMAGED. ISSUES DID NOT OCCUR DURING SURGERY. SIGMA HP UNI TIB CUT BLK LM/RL (X2) ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY. SIGMA HP UNI TIB CUT BLK RM/LL - CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY. SIGMA HP UNI ANTERIOR CHISEL ¿ CHISEL END SNAPPED INTO TWO PIECES, PIECES BOTH DISPOSED OF. SIGMA HP UNI AP KEEL OSTEOTOME ¿ METAL KEEL END BENT, NO LONGER FIT FOR USE. SIGMA HP UNI FB KEEL OSTEOTOME - METAL KEEL END BENT, NO LONGER FIT FOR USE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22018341 ↗MalfunctionDec 2, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE METAL BACK AND ALL POLY GOUGE BROKE. LM AND RM TIBIA CUT GUIDES ARE BENT.
Patient problems: Insufficient Information
MAUDE report 20824665 ↗MalfunctionJun 26, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ISSUE WAS THAT ITEMS WERE BENT AND WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19620099 ↗MalfunctionApr 3, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19030824 ↗MalfunctionNov 6, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS NEED REPLACING DUE TO WEAR AND TEAR AND ARE NO LONGER USABLE FOR SURGERY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT OR SURGERY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081019 ↗MalfunctionJul 18, 2023Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED. A. WHAT PART OF THE INSTRUMENT BROKE? THE BIT AT THE TOP. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY, WHAT IS THE ALLEGED DEFICIENCY, IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN, OR CROSS-THREADED? NO, IT'S BENT. C. PLEASE VERIFY, IF THE INSTRUMENT WAS USED, DURING SURGERY OR NOT? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17343633 ↗MalfunctionMay 24, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY TODAY AT EPSOM HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991538 ↗MalfunctionApr 28, 2023Scratched Material; Scratched Material
IT WAS REPORTED THE SURFACES OF THE INSTRUMENTS ARE DEEPLY GOUGED AND SCRAPED FROM SAW USAGE. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16831613 ↗MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE WAS REPORTED FOR UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443291 ↗MalfunctionJan 9, 2023Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED AND COULD NOT BE PROPERLY CLEANED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16121601 ↗MalfunctionOct 28, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THE LM CUTTING BLOCK ON SIGMA PARTIAL SET IS DAMAGED. WONT ACCEPT PINS DUE TO WEAR AND TEAR. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15693804 ↗MalfunctionJul 26, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT BOTH OF THE TIBIAL CUTTING BLOCKS ARE SEVERELY DAMAGED THROUGH WEAR AND TEAR. NO PATIENT HARM OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103196 ↗MalfunctionFeb 4, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THESE BLOCKS ARE VERY WORN DUE TO HIGH USAGE. THE SAW SPACE IS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13451376 ↗MalfunctionFeb 4, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THESE BLOCKS ARE VERY WORN DUE TO HIGH USAGE. THE SAW SPACE IS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13451374 ↗MalfunctionFeb 4, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THESE BLOCKS ARE VERY WORN DUE TO HIGH USAGE. THE SAW SPACE IS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13451373 ↗MalfunctionSep 22, 2021Naturally Worn; Naturally Worn
WE HAVE A HANDLE THAT¿S REQUIRED ON A SET AS IT ONLY HAS ONE AND SHOULD HAVE TWO. THE OTHERS ARE DUE TO WEAR ON TEAR ON THE CURRENT ONES SO THEY NEED REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12517199 ↗MalfunctionSep 22, 2021Naturally Worn; Naturally Worn
WE HAVE A HANDLE THAT¿S REQUIRED ON A SET AS IT ONLY HAS ONE AND SHOULD HAVE TWO.THE OTHERS ARE DUE TO WEAR ON TEAR ON THE CURRENT ONES SO THEY NEED REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12517196 ↗MalfunctionSep 14, 2021Naturally Worn; Naturally Worn
INSTRUMENTS ARE BEING REPORTED DUE TO WEAR AND TEAR ON THE CURRENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468458 ↗MalfunctionSep 14, 2021Naturally Worn; Naturally Worn
INSTRUMENTS ARE BEING REPORTED DUE TO WEAR AND TEAR ON THE CURRENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468450 ↗MalfunctionJul 1, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT SSD NOTICED THE CUTTING BLOCKS WERE VERY WORN AND NO LONGER FUNCTIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12105243 ↗MalfunctionJul 1, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT SSD NOTICED THE CUTTING BLOCKS WERE VERY WORN AND NO LONGER FUNCTIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12105242 ↗MalfunctionMar 31, 2021Device-Device Incompatibility; Device-Device Incompatibility
SURGEON JAMMED A DRILL PIN IN A SIGMA PARTIAL CUTTING BLOCK WHEN REMOVING THE BLOCK AFTER CUTTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11598710 ↗MalfunctionNov 24, 2020Scratched Material; Scratched Material
IT WAS REPORTED THAT DURING POST CLEANING INSPECTION THESE CUT BLOCKS WERE FOUND TO HAD DEEP GROVES CUT INTO THE TOPS OF THE BLOCKS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10894848 ↗
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
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 reports
- ATTUNE 2545-00-157Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC37 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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