SIGMA LCS 9505-02-028Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE TIBIAL TRAY HANDLE · Class 1
All models of SIGMA LCS (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy instrument handle used to position the tibial tray during knee replacement surgery. The 33 reports mostly describe handles breaking or bending, sometimes releasing small bits of silicone, and a few mention the handle would not hold the trial in place or issues with cleaning. None of the reports describe a death or an injury, and 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295227489), received between Jul 21, 2017 and Jun 28, 2023 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (28 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.
Most reported problems
Device problems
- Break28
- Device-Device Incompatibility3
- Contamination /Decontamination Problem2
- Material Twisted/Bent2
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient12
- No Information5
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? IT DID NOT LEAD TO DELAY IN SURGERY. 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT, BECAUSE OF THE REPORTED EVENT? THERE WAS NO CONSEQUENCE FOR THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17218419 ↗MalfunctionFeb 9, 2023Break; Break
IT WAS REPORTED THE HANDLES ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16335232 ↗MalfunctionFeb 9, 2023Break; Break
IT WAS REPORTED THE HANDLES ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16335231 ↗MalfunctionFeb 9, 2023Break; Break
IT WAS REPORTED THE HANDLES ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16335226 ↗MalfunctionJan 4, 2023Break; Break
IT WAS REPORTED THAT THE HANDLE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096119 ↗MalfunctionNov 1, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL TRIAL HANDLE WON¿T RETAIN TIBIAL TRIAL. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15711086 ↗MalfunctionSep 12, 2022Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
WE HAVE SETS OF TOTAL KNEE IN CIRCULATION HERE THAT ARE ON CONSIGNMENT. NOW THERE ARE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED, THESE ARE: PAT. CEMENTING CLAMP 86-5035 (RED RUBBER CAP OF CLAMP IS BROKEN, RELEASES PARTICLES). HP TIBIAL TRAY HANDLE 950502028 (BACK OF HANDPIECE IS BROKEN AND RELEASE BITS OF SILICONE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15401854 ↗MalfunctionJul 26, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN USED TOGETHER AND HAVE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15104117 ↗MalfunctionJun 16, 2022Break; Break
THE TWO PINS THAT ENGAGE THE TRAY SNAPPED OFF WHEN IT WAS INSERTED INTO THE TIBIAL TRAY TRIAL. FRAGMENTS PRODUCED AND RETRIEVED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14722291 ↗MalfunctionJan 27, 2022Break; Break
IT WAS REPORTED THAT THE ATTACHMENT NUBS FOR THE TIBIA HANDLE BROKE OFF INTO THE FBT TRIAL. BOTH NEED TO BE REPLACED. ALL PIECES WERE RETRIEVED. THERE WAS A SURGICAL DELAY OF 2 MINUTES.
Patient problems: Insufficient Information
MAUDE report 13366170 ↗MalfunctionSep 21, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLE GOT STUCK IN THE TRAY AND WE COULD NOT GET IT TO RELEASE. IT WAS ALSO VERY SLOW TO MOVE, LIKE THE CYLINDER INSIDE THE HANDLE HAD SOME ISSUE. THERE WAS NO PROBLEM WITH THE TRAY. THIS INSTRUMENT WAS NOT USED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12508829 ↗MalfunctionSep 21, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLE GOT STUCK IN THE TRAY AND WE COULD NOT GET IT TO RELEASE. IT WAS ALSO VERY SLOW TO MOVE, LIKE THE CYLINDER INSIDE THE HANDLE HAD SOME ISSUE. THERE WAS NO PROBLEM WITH THE TRAY. THIS INSTRUMENT WAS NOT USED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12506670 ↗MalfunctionAug 31, 2021Break; Break
IT WAS REPORTED THAT THE RUBBER HANDLES ARE STARTING TO DISINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12391320 ↗MalfunctionJun 30, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
QUESTIONS: 1. WHAT PART OF THE INSTRUMENT BROKE? 2. DID IT BREAK INTO TWO OR MORE PIECES? ANSWERS: 1) DISTAL PART OF HANDLE WORN AND FAILED TO ENGAGE INTO TIBIAL TRAY TRIAL. 2) ONE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12092376 ↗MalfunctionApr 26, 2021Break; Break
CUSTOMER IS COMPLAINING THE INSTRUMENT´S PLASTIC HANDLE. THE PLASTIC IS COMING OFF. NO ADVERSE PATIENT IMPACT, NO SURGERY DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11724858 ↗MalfunctionDec 8, 2020Break; Break
AS THE SURGEON WAS EXTRACTING THE TIBIAL TRIAL WITH THE TIBIAL TRIAL HANDLE, ONE OF THE PRONGS THAT CONNECTS THE HANDLE TO THE TIBIAL BASEPLATE SNAPPED OFF. ALL OF THE PIECES WERE RETRIEVED FROM THE PATIENT. THE SCRUB TECH DISCARDED THE BROKEN HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10970181 ↗MalfunctionNov 3, 2020Break; Break
IT WAS REPORTED THAT THE PEG BROKE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10778668 ↗MalfunctionAug 19, 2020Break
IT WAS REPORTED THAT THE PRONGS BROKE OFF RP TRAY HANDLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10427424 ↗MalfunctionJul 15, 2020Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING REMOVAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10278310 ↗MalfunctionJul 14, 2020Break; Break
IT WAS REPORTED THAT DURING INSERTION OF THE TRIAL TIBIA INTO THE KNEE, ONE CONNECTION PRONG BROKE OFF INTO THE TRIAL TIBIA FROM THE TRIAL TIBIA BASE PLATE HANDLE. ALL PIECES WERE RECOVERED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10272276 ↗MalfunctionJun 17, 2020Break; Break
SURGEON WAS REMOVING TIBIAL TRAY WITH INSERTER. INSERTER PEGS BROKE OFF OF THE SIGMA HP INSERTER HANDLE. TRAY WAS DAMAGED AS WELL WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY, UNKNOWN, IP-00900914 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-00900915 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10166047 ↗MalfunctionFeb 17, 2020Contamination /Decontamination Problem; Material Twisted/Bent; Contamination /Decontamination Problem; Material Twisted/Bent
HANDLE IS WORN AND HAS A GREASY FILM ON IT THAT CAN¿T BE REMOVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9718699 ↗MalfunctionJul 25, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE KEEL IMPACTOR HANDLE WAS MISSING SET SCREW TO HOLD IN BUTTON AND THE TRAY HANDLE WAS WORN OUT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8827752 ↗MalfunctionMay 23, 2019Break; Break
IT WAS REPORTED THAT THE TIBIAL TRAY HANDLE BROKE INTO 3 PIECES. SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8636926 ↗MalfunctionOct 4, 2018Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. FOLLOW UP DETERMINED THAT THE TIP OF THE INSTRUMENT HANDLE BROKE AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7934165 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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