SIGMA 9505-01-205Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE SYMMETRIC TIBIAL CUTTING BLOCK 3 DEG · Class 1

All models of SIGMA (380)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295225133), received between Oct 25, 2019 and Aug 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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

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

Most reported problems

Device problems

Device-Device Incompatibility2

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN WAS JAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20036999 ↗
MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
PIN STUCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241567 ↗

Device details

UDI-DI	`10603295225133`
Brand	SIGMA
Model	9505-01-205
Catalog no.	950501205
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.

Other INSTRUMENT, CUTTING, ORTHOPEDIC devices

SIGMA LCS 9505-01-230
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
95 reports
ATTUNE 2544-00-522
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
58 reports
SIGMA LCS 9505-01-229
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
56 reports
SIGMA 2024-40-100
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
43 reports
ATTUNE 2545-00-158
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
41 reports
ATTUNE 2545-00-156
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
41 reports
SIGMA 2024-40-200
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
40 reports
ATTUNE 2545-00-155
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
39 reports

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 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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