SIGMA LCS 9505-01-228Recalls & reported problems

Depuy (Ireland) · SIGMA LCS HIGH PERFORMANCE EM TIBIAL JIG UPROD · Class 1

All models of SIGMA LCS (20)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 15
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295225331), received between Dec 13, 2017 and Mar 8, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device-Device Incompatibility8
Material Twisted/Bent3
Mechanical Jam2
Appropriate Device Problem Term/Code Not Available1
Break1

Patient problems

No Clinical Signs, Symptoms or Conditions9
No Consequences Or Impact To Patient7

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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 18865080 ↗
MalfunctionFeb 23, 2024Break; Break
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 18766353 ↗
MalfunctionJun 26, 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 17202353 ↗
MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087354 ↗
MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087349 ↗
MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087345 ↗
MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087335 ↗
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 12605667 ↗
MalfunctionJun 18, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE INSTRUMENT ARE BOUND UP NOT WORKING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10167441 ↗
MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent
INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616632 ↗
MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent
INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616625 ↗
MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent
INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8615968 ↗
MalfunctionOct 15, 2018Mechanical Jam; Mechanical Jam
TIBIAL JIG FROZE AND WAS NOT ABLE TO MOVE INTO THE REQUIRED POSITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7966808 ↗
MalfunctionJul 20, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS BROUGHT TO MY ATTENTION BY THE CENTRAL STERILE PERSON THAT THE TIBIAL UPROD WAS UNABLE TO BE TAKEN APART.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7706876 ↗
MalfunctionDec 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
POOR CUTTING ACCURACY. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 7112551 ↗

Device details

UDI-DI	`10603295225331`
Brand	SIGMA LCS
Model	9505-01-228
Catalog no.	950501228
Company	Depuy (Ireland)
Product code	HTZ · INSTRUMENT, CUTTING, ORTHOPEDIC
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 6, 2024

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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ATTUNE 2545-00-158
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All INSTRUMENT, CUTTING, ORTHOPEDIC devices →

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 13, 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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