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JOURNEY 74013464Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY UNI 2 IN 1 FEMORAL BLOCK RIGHT MEDIAL SIZE 4 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010627100), received between Jun 23, 2020 and Jun 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Protrusion/Extrusion1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 23, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT RUST WAS FOUND IN THE CUTTING BLOCK BEFORE THE SURGERY STARTED. THE TECH SENT THE CASE TO SAFETY PROCESSING AND INFECTIOUS CONTROL. HOSPITAL HAS REQUESTED TO REPLACE THE ITEM AFFECTED AND WILL NOT PROCESS TRAYS UNTIL REPLACED. PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10183472 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.