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JOURNEY 71422404Recalls & reported problems

Smith & Nephew, Inc. · JOURNEYUNI ALL POLY TIBIA SIZE 4LEFT MEDIAL/RIGHT LATERAL7MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010593597), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

  • Loss of Osseointegration1

Patient problems

  • Inadequate Osseointegration1

Recent adverse event reports

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

  • InjurySep 7, 2022Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT, AFTER A LEFT UKA SURGERY PERFORMED IN (B)(6) 2013, PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXCHANGE THE FEMORAL AND TIBIAL COMPONENTS, AND THE INSERT. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 15375378 ↗

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.