SIGMA LCS 9505-01-229Recalls & reported problems
Depuy (Ireland) · SIGMA LCS HIGH PERFORMANCE EM TIBIAL JIG ANKLE CLAMP · 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 tibial jig ankle clamp is a surgical alignment instrument used during hip replacement. The 56 reports mostly describe metal parts breaking, snapping or jamming mid-operation — screws that strip or break off, dials and clamps that seize, pieces missing from loaner kits — and problems fitting with other instruments. No deaths or injuries were reported, and most cases left 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10603295225348), received between Sep 26, 2017 and Jul 9, 2025 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break15
- Device-Device Incompatibility15
- Mechanical Jam12
- Appropriate Device Problem Term/Code Not Available4
- Naturally Worn4
- Material Deformation3
- Material Twisted/Bent3
- Structural Problem3
Patient problems
- No Consequences Or Impact To Patient29
- No Clinical Signs, Symptoms or Conditions24
- No Information2
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THE SCREW IS NOT WORKING/BROKEN. SURGEON HAD TO HOLD IN PLACE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22463053 ↗MalfunctionMay 29, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT BLUE SCREW WAS STRIPPED. IT WOULD NOT TIGHTEN DOWN. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES. THE PRODUCT WAS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107058 ↗MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IN IT WAS NOTICED THAT THE INSTRUMENT WAS MISSING PART 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078045 ↗MalfunctionJun 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A SCREW BROKE OFF AND IS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19457360 ↗MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: NO THIS ISSUE WAS DISCOVERED PRE-SURGERY. NO IMPACT ON THE PATIENT OR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865075 ↗MalfunctionFeb 21, 2024Break; Break
IT WAS REPORTED THAT THE PRODUCT BROKE IN 2 PARTS DURING THE IMPACTION OF THE FEMUR. FOR THE OTHER PRODUCT: THE SCREW OF THE BRACELET BROKE IN THE SCREW THREAD. IT WAS IMPOSSIBLE TO DISASSEMBLE IT FOR USE. THE IMPACTED PRODUCTS WERE IN CONTACT WITH THE PATIENT. NO PATIENT CONSEQUENCE. NOTHING TO REPORT REGARDING THE ACTUAL STATE OF THE PATIENT. THE SURGICAL TECHNICAL HAD BEEN CHANGED: MANUAL IMPLANTATION, SO LESS PRECISE MANAGEMENT OF POSITIONING AND ROTATION. SURGICAL DELAY OF 15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18749630 ↗MalfunctionJan 18, 2024Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility
IT WAS REPORTED THAT DIAL WILL NOT TIGHTEN. IT DID NOT AFFECT PATIENT OR SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535332 ↗MalfunctionJun 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ANKLE CLAMP SEIZED DURING SURGERY. THERE WAS NO IMPACT ON THE SURGERY ITSELF IT WAS NOTED WHEN IT CAME TO DISMANTLE THE INSTRUMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17184051 ↗MalfunctionApr 4, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THE SCREWS IN THE CONNECTING PART OF THE DEVICE WERE HARD, MAKING IT DIFFICULT TO FIX THE DEVICE IN PLACE, AND EVEN IF IT WAS FIXED, IT WOULD LOOSEN IMMEDIATELY. LAST WEDNESDAY (15TH), THE SCREW OF THE SAME DEVICE WAS HARD, BUT THERE WERE NO FIXATION PROBLEMS, SO THE SURGEON PERFORMED THE OPERATION WITH THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674430 ↗MalfunctionJan 26, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE UPROD SCREW ON ANKLE CLAMP IS CROSS-THREADED. ANKLE CLAMP MEDIALIZER ALSO WON¿T MOVE. BOTH LINER TRIALS ALSO CHIPPED UPON REMOVAL. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16246229 ↗MalfunctionDec 14, 2022Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BLUE SCREW WON¿T ENGAGE TO LOCK ROD INTO PLACE ON ANKLE CLAMP. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15983799 ↗MalfunctionOct 3, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ALL ITEMS WERE BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15532455 ↗MalfunctionJun 20, 2022Structural Problem; Naturally Worn; Structural Problem; Naturally Worn
PARTIAL KNEE TIBIAL JIG WORN AND NO LONGER WORKING CORRECTLY. MAIN CENTRAL CONNECTOR NOT TIGHTENING FULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14743599 ↗MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A CASE THE TEAM AT THE HOSPITAL WERE UNABLE TO REMOVE THE TIBIAL JIG PARTS FROM THE SIGMA HP KIT. THERE WAS A SURGICAL DELAY OF FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194136 ↗MalfunctionFeb 15, 2022Mechanical Jam; Mechanical Jam
DURING A CASE TODAY A TIBIAL JIG BECAME STUCK AND WOULD NOT MOVE UP AND DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13539329 ↗MalfunctionFeb 1, 2022Mechanical Jam; Mechanical Jam
THE BLUE KNOB ON THE SIGMA TIBIAL EM GUIDE IS STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13419682 ↗MalfunctionDec 7, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING KNEE SURGERY TODAY THE INSTRUMENT WAS BROKEN. THE KNOB WAS NOT TURNING ON THE INSTRUMENT IN ORDER TO ALLOW THEM TO PUT THE JIGS TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12953584 ↗MalfunctionDec 2, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT A SCREW ON THE BELOW TIBIAL JIG KEEPS STICKING AND WILL NOT UNSCREW. THEY HAVE LOOSENED IT, LUBRICATED IT AND THE SCREW KEEPS GETTING STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12915885 ↗MalfunctionNov 17, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT IS NO LONGER USEABLE DUE TO WEAR AND TEAR PFC. NO SURGICAL DELAY. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828199 ↗MalfunctionNov 9, 2021Material Deformation; Mechanical Jam; Naturally Worn; Material Deformation; Mechanical Jam; Naturally Worn
BLUE LOCKING BUTTON WAS STUCK AND APPEARS TO HAVE BEEN BENT AND/OR CROSSED THREADING. DELAY TO SURGERY OF A FEW MINUTES BUT KNOB WAS RELEASED AND USEABLE THOUGH NOW APPEARS BENT. THERE WAS NO ISSUES WITH OUTCOME OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12778975 ↗MalfunctionOct 11, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ANKLE CLAMP AND JIG STUCK TOGETHER. UNABLE TO SEPARATE FOR STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605665 ↗MalfunctionMay 5, 2021Break; Break
IT WAS REPORTED THAT THE BLUE SET SCREW ON THE EM TIBIAL JIG ANKLE CLAMP BROKE AND IS NOT ABLE TO BE USED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11779000 ↗MalfunctionJan 8, 2021Break; Break
IT WAS REPORTED THAT BROKEN ITEMS WERE FOUND IN WASH. PARTS ARE BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11139380 ↗MalfunctionSep 8, 2020Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE ANKLE CLAMP AND EM TIBIA JIG STUCK TOGETHER AND BLUE SCREW BROKE OFF. SCREW BROKE OFF TRYING TO GET THEM UNSTUCK. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10505564 ↗MalfunctionAug 12, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE BLUE SCREW IS STRIPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10396854 ↗
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 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
- 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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