SIGMA LCS 9505-01-230Recalls & reported problems
Depuy (Ireland) · SIGMA LCS HIGH PERFORMANCE EM TIBIAL JIG SPIKED UPROD · Class 1
All models of SIGMA LCS (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma LCS tibial cutting guide has 95 adverse event reports describing broken or bent spikes, detached components, and device-device incompatibility. Reports mention no deaths and no injuries. No recalls name this device. Reports fell from 7 to 3 over the last two 12-month periods.
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
- 95
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10603295225355), received between Sep 27, 2017 and Jun 10, 2026 — classified as 95 malfunctions.
The most frequently reported specific device problem is “Break” (48 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
- Break48
- Material Deformation20
- Material Twisted/Bent11
- Device-Device Incompatibility7
- Detachment of Device or Device Component6
- Adverse Event Without Identified Device or Use Problem3
- Physical Resistance/Sticking3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- No Consequences Or Impact To Patient34
- Insufficient Information6
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Break
IT WAS REPORTED THAT DURING MDRD INSPECTION, IT WAS DISCOVERED THAT ONE OF THE SPIKES ON THE JIG HAD BROKEN OFF AND THEREFORE THE ITEM WAS NO LONGER FUNCTIONAL. PRODUCT HAS BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461117 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT THE EM TIBIAL CUTTING GUIDE WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886494 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT THE SPIKE TOP FELL OFF AND THE EM TIBIAL CUTTING GUIDE BROKE INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483631 ↗MalfunctionSep 10, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23015505 ↗MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, MISSING THE LONGER SPIKE AND THE LONGER SPIKE OF THE 2 IS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22840777 ↗MalfunctionJun 3, 2025Break; Break
DURING MDRD INSPECTION, THE PIN TO KEEP THE SPIKED TOP OF THE GUIDE FROM DISCONNECTING WAS BROKEN OFF AND DEVICE WAS NO LONGER USABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133224 ↗MalfunctionMay 26, 2025Incorrect Measurement; No Apparent Adverse Event; Incorrect Measurement; No Apparent Adverse Event
IT WAS REPORTED THAT THE TIBIAL GUIDE WAS NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084865 ↗MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PARTS CAME DISASSEMBLED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20759809 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED THAT THE PART SEPARATED INTO 2 PARTS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20685934 ↗MalfunctionNov 1, 2024Break; Break
IT WAS REPORTED, THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024. THE SLIDING MECHANISM OF THE INSTRUMENT SEPARATED. UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20587789 ↗MalfunctionSep 16, 2024Break; Material Deformation; Unintended Movement; Break; Material Deformation; Unintended Movement
IT WAS REPORTED THAT THE PROXIMAL SECTION SLIDES OFF THE UP-ROD, SPIKES ARE BENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224296 ↗MalfunctionAug 13, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT TOP PORTION SLIDE STOP MALFUNCTIONS. IT WON'T STAY IN PLACE. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19971122 ↗MalfunctionAug 13, 2024Break; Break
IT WAS REPORTED THAT IMPACTOR PLASTIC FLAKING OFF AND EM GUIDE- TOP PORTION FALLING OFF.
Patient problems: Insufficient Information
MAUDE report 19971045 ↗MalfunctionApr 29, 2024Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA FOR WITH TIBIAL JIG ANKLE CLAMP AND TIBIAL JIG SPIKE UP ROD IN QUESTION. ON (B)(6) 2022, THE DAY BEFORE THE SURGERY, THE TWO PRODUCTS IN QUESTION WERE DELIVERED, AND WHEN THE PRODUCTS WERE ASSEMBLED BY THE NURSE, SHE NOTICED THAT THE ORIGINAL CENTER SPIKE OF THE TIBIAL JIG SPIKE UP ROD WAS SLIGHTLY BENT. THE SALES REP WAS POINTED THIS OUT OVER THE PHONE BUT WAS UNABLE TO DETERMINE THE SITUATION OVER THE PHONE, SO TWO ADDITIONAL REPLACEMENT INSTRUMENT SETS WERE SHIPPED. THE SALES REP DELIVERED THEM THE NEXT DAY, ON THE 23RD, AND COMPARED THE DIFFERENCES BETWEEN THE TWO PRODUCTS IN QUESTION AND ADDITIONAL REPLACEMENT INSTRUMENTS. THE CONCLUSION WAS THAT THERE WAS NO SIGNIFICANT DIFFERENCE. IT WAS ASSUMED THAT THE ASSEMBLY WAS NOT SECURELY FASTENED, AND THE SPIKE WAS SLIGHTLY MISALIGNED. THE NURSE CONFIRMED THE CONDITION OF THE TWO PRODUCTS IN QUESTION AND THESE WERE USED IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19201072 ↗MalfunctionApr 2, 2024Break; Break
IT WAS REPORTED THAT THE PIN BROKE OFF UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19028509 ↗MalfunctionMar 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TOP DETACHED FROM THE UPRIGHT PART OF THE DEVICE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825840 ↗MalfunctionFeb 7, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SPIKES ON THE TIBIAL JIG WERE BENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660197 ↗MalfunctionFeb 7, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SPIKES ON THE TIBIAL JIG WERE BENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660194 ↗MalfunctionJan 18, 2024Break; Break
IT WAS REPORTED THAT ONE OF THE SPIKES OF AN INSTRUMENT BROKE OFF AFTER THE PROCEDURE. NO PATIENT WAS HARMED, NO OPERATION DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534344 ↗MalfunctionDec 6, 2023Break; Break
IT WAS REPORTED THAT ONE OF THE SPIKES BROKE OFF DURING CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18274111 ↗MalfunctionOct 17, 2023Break; Break
IT WAS REPORTED THAT THE FRONT TIBIAL SPIKE BROKE OFF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17949500 ↗MalfunctionOct 9, 2023Break; Break
IT WAS REPORTED THAT PARTS CAME APART. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17898033 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT UPPER PART NO LONGER ATTACHED TO THE LOWER PART OF THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17859898 ↗MalfunctionJun 5, 2023Break; Break
IT WAS REPORTED THAT THE MECHANISM BROKE THAT HOLDS THE SPIKED PORTION TO THE UPROD. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17059183 ↗MalfunctionApr 4, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE DEVICE HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673855 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- 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
- 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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