SIGMA 2024-40-200Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE TIBIAL CUTTING BLOCK RM/LL · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy SIGMA partial knee tibial cutting block is a surgical tool for knee procedures. Reports mostly describe cutting slots or blocks wearing down, bending, breaking, or becoming unusable. There are 40 adverse event reports, with no deaths and no injuries. There are no recalls for 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295082989), received between Jul 18, 2017 and May 16, 2025 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 Incompatibility10
- Naturally Worn10
- Material Deformation6
- Scratched Material5
- Break4
- Physical Resistance/Sticking4
- Appropriate Device Problem Term/Code Not Available3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient13
- Insufficient Information3
- No Information3
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 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)SO2044861 - 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)SO2044861 - 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)SO2045688 - 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 22034819 ↗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 20824783 ↗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 19620104 ↗MalfunctionApr 3, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TIBIAL CUTTING BLOCKS LM AND RM WERE VERY WORN DOWN; JUST WEAR AND TEAR ON INSTRUMENTS. THEY ARE VERY CLOSE TO COMPLETELY SNAPPING WHERE THE BREADKNIFE SAW IS USED VERTICALLY ON THE TIBIAL CUTTING BLOCK. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19030826 ↗MalfunctionApr 1, 2024Break; Break
ITEMS ARE BROKEN AND NO LONGER FIT FOR PURPOSE. NO PATIENT CONSEQUENCE OR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011942 ↗MalfunctionNov 6, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS NEED REPLACING DUE TO WEAR AND TEAR AND RE 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 18081020 ↗MalfunctionMay 24, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY TODAY AT (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991551 ↗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 16831614 ↗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 16121631 ↗MalfunctionSep 15, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRIVE TIP WAS SHEARED OFF AS WE ATTEMPTED TO RELEASE IT FROM THE CUTTING JIG. ALL PARTS WERE RECOVERED. THERE WAS MINIMAL DELAY TO THE OPERATION TIME AND NO CHANGE IN DIRECTION OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15429078 ↗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 15103230 ↗MalfunctionMay 26, 2022Device-Device Incompatibility; Device-Device Incompatibility
THE INSTRUMENTS DID NOT PERFORM AS INTENDED. THE SPACER BLOCK BROKE AT THE HANDLE AND ALL PIECES WERE RETRIEVED. THE FIXATION PIN COLD WELDED TO THE RM/LL TIBIAL RESECTION BLOCK. THE UNIVERSAL HANDLE WAS NOT CAPTURING SECURELY. SURGICAL DELAY OF 5 MINUTES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14516516 ↗MalfunctionMay 26, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE RM/LL CUTTING BLOCK WAS BEYOND ITS USEFUL LIFE. THERE WERE MANY CUTTING MARKS ON IT AND IT SHOULD BE REPLACED. THIS WAS NOT USED IN A SURGERY, ONLY A CADAVER LAB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14515481 ↗MalfunctionFeb 4, 2022Material Deformation; Material Deformation
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 13451375 ↗MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A SURGERY. THERE WAS A DELAY OF 1-2 MINUTES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13077264 ↗MalfunctionDec 7, 2021Device-Device Incompatibility; Device-Device Incompatibility
PIN IS STUCK IN SIGMA PARTIAL TIBIAL CUTTING BLOCK RM / LL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12951144 ↗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 12517198 ↗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 12517197 ↗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 12468489 ↗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 12468464 ↗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 12105241 ↗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 10894920 ↗MalfunctionOct 12, 2020Naturally Worn; Naturally Worn
THE CUTTING BLOCKS ARE WORN AND I ORDERED IN REPLACEMENTS TO SWAP OUT WITH NEW CUTTING BLOCKS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10663445 ↗MalfunctionJan 13, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
I HAVE JUST BEEN MADE AWARE OF A HEADED DRILL PIN THAT GOT STUCK IN THE TIBIAL RESECTION GUIDE ON (B)(6) 2019. THE HOSPITAL WAS UNABLE TO REMOVE PIN FROM THE GUIDE AND HAS BROKEN AFTER CASE WHILST TRYING TO REMOVE PIN FROM GUIDE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9582720 ↗MalfunctionDec 18, 2019Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
IT WAS REPORTED THAT THE DURING POST CLEANING INSPECTION THE SIZING ARM WAS FOUND TO HAD BEEN BENT AND THE 2 CUT BLOCKS HAD GOUGES ACROSS THE TOP. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9491795 ↗
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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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