SIGMA LCS 9505-01-203Recalls & reported problems
Depuy (Ireland) · SIGMA LCS HIGH PERFORMANCE IM TIBIA JIG · Class 1
All models of SIGMA LCS (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy SIGMA LCS high performance tibial jig is a surgical alignment guide used to set the angle of the tibia bone during knee replacement. The 33 reports mostly describe metal parts breaking, bending, wearing out or jamming, with settings that drift or would not hold and a dial that would not turn. No deaths and no injuries were reported. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295225119), received between Aug 18, 2017 and Mar 24, 2025 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Appropriate Device Problem Term/Code Not Available4
- Material Deformation4
- Device-Device Incompatibility3
- Mechanical Jam3
- Naturally Worn3
- Physical Resistance/Sticking3
- Incorrect Measurement2
Patient problems
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions11
- Not Applicable3
- Insufficient Information2
- No Information2
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREADS ON THE DEVICE WERE STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21678452 ↗MalfunctionJan 31, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT IM CUTTING GUIDE DID NOT ALLOW FOR SLOPE ADJUSTMENTS. ANOTHER WAS AVAILABLE AND THE CASE PROCEEDED WITHOUT DELAY. THERE WAS NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21288521 ↗MalfunctionJan 16, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE BLUE DIAL ON THE JIG WILL NOT ROTATE AND NEEDS REPLACING.
Patient problems: Insufficient Information
MAUDE report 21167142 ↗MalfunctionJul 21, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE IM TIBIAL JIG POSTERIOR SLOPE ADJUSTMENT HAS TOO MUCH ¿PLAY¿ WHEN ATTACHED TO THE OUTRIGGER, IMPEDING THE ABILITY TO GET A PREDICTABLE AND PRECISE SETTING FOR TIBIAL POSTERIOR SLOPE. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17370564 ↗MalfunctionJan 11, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT SIGMA IM TIBIAL JIG WILL NOT HOLD TIBIAL CUTTING BLOCK. POSSIBLY THE TWO POST THAT HOLD THE BLOCK ARE BENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16138208 ↗MalfunctionNov 7, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE DURING FINAL INSERTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742802 ↗MalfunctionAug 22, 2022Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT THE L SHAPED PIECE ON THE SIGMA IM TIBIA GUIDE WAS DAMAGED AND THE ROD COULD NOT FIT THROUGH THE HOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15267207 ↗MalfunctionAug 19, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE THREAD ON THE SCREW IS STRIPPED. OCCURRED BEFORE CASE STARTED. INSTRUMENT WAS USED IN CASE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258261 ↗MalfunctionOct 28, 2021Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS NOTED THAT THE SCREW ON THE IM TIBIA JIG WAS STUCK AND WOULD NOT SCREW OR UNSCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12711863 ↗MalfunctionSep 29, 2021Break; Break
IT WAS REPORTED THAT THE BLUE KNOBS ON IM TIBIA JIG BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12546994 ↗MalfunctionSep 29, 2021Break; Break
IT WAS REPORTED THAT THE BLUE KNOBS ON IM TIBIA JIG BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12546992 ↗MalfunctionAug 4, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HEIGHT ADJUSTMENT KNOB ON THE PFC IM TIBIAL RESECTION GUIDE WAS NOT ENGAGING. IT APPEARS THE THREADS ON THE SCREW ARE NOT ENGAGING WITH THE GROOVES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274087 ↗MalfunctionDec 17, 2020Material Integrity Problem; Material Integrity Problem
BLUE THUMB SCREW ON INTRAMEDULLARY JIG IS FAULTY. USED EXTRAMEDULLARY ALIGNMENT GUIDE AS THE ALTERNATIVE. NO SURGICAL DELAY. PROCEDURE COMPLETED WITHOUT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11027428 ↗MalfunctionMay 28, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE KNOB THAT TIGHTENS THE SIGMA IM TIBIAL JIG WAS STRIPPED. NO FURTHER INFORMATION WAS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10097833 ↗MalfunctionDec 5, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE BOLT WAS STRIPPED ON DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9418238 ↗MalfunctionSep 3, 2019Break; Break
IT WAS REPORTED THAT THE BLUE SCREW KNOB WAS BROKEN OF THE IM TIBIA JIG DURING SURGERY. IT WAS RETRIEVED AND WAS DISCARDED BY OPERATION ROOM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957803 ↗MalfunctionJul 2, 2019Break; Break
IT WAS REPORTED THAT THE BLUE SCREW WAS BROKE OFF IM TIBIA JIG. BOTH PIECES RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8754714 ↗MalfunctionJun 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
CLIENT REQUESTS THE CHANGE OF THE EXTRA MEDULLARY GUIDE OF TIBIAL CUT CODE (B)(4), SINCE IT IS LOCKED IN ITS USE AND THAT MODIFIES THE TIBIAL CUT. ALREADY NEED REPLACEMENT FOR SMOOTH PINS, WHICH WEAR AND TWIST DURING SURGERIES. HP IM TIBIA JIG WAS STUCK.
Patient problems: Not Applicable
MAUDE report 8726698 ↗MalfunctionJun 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
CLIENT REQUESTS THE CHANGE OF THE EXTRA MEDULLARY GUIDE OF TIBIAL CUT CODE (B)(4), SINCE IT IS LOCKED IN ITS USE AND THAT MODIFIES THE TIBIAL CUT. ALREADY NEED REPLACEMENT FOR SMOOTH PINS, WHICH WEAR AND TWIST DURING SURGERIES. HP IM TIBIA JIG WAS STUCK.
Patient problems: Not Applicable
MAUDE report 8726696 ↗MalfunctionMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
MalfunctionMar 28, 2019Use of Device Problem
IT WAS REPORTED THAT THE TIBIAL JIG HAS TO MUCH TO PLAY IN IT WHEN SETTING THE SLOPE. WHEN COMPARED TO OTHER JIGS THERE WAS A SIGNIFICANT DIFFERENCE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8460642 ↗MalfunctionMar 21, 2019Break; Break
IT WAS REPORTED THAT THE BLUE SCREW KNOB OF THE IM TIBIA JIG WAS BROKEN OFF DURING SURGERY. IT WAS RETRIEVED. DISCARDED BY HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8441145 ↗MalfunctionOct 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IM TIBIAL JIG BLUE KNOB WOULD NOT TIGHTEN/LOOSEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7957546 ↗MalfunctionOct 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
BLUE KNOB ON THE FRONT WASN'T LOCKING INTO PLACE WHEN ADJUSTING THE LEVEL OF RESECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7927329 ↗MalfunctionSep 24, 2018Incorrect Measurement; Appropriate Device Problem Term/Code Not Available; Incorrect Measurement; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE HP, IM TIBIAL JIG IS NOT WORKING , YOU CAN NOT ADJUST THE DEGREE OF SLOPE. THE PART #/LOT # ARE WORN OFF CAN NOT READ WHAT THEY ARE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7902925 ↗
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 2545-00-156Depuy (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
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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