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JOURNEY 71422422Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2 · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556087893), received between Aug 1, 2019 and Jun 8, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K102069, K230653); they may or may not involve this specific model.

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

  • Loosening of Implant Not Related to Bone-Ingrowth2

Patient problems

  • Inadequate Osseointegration1
  • Injury1

Recent adverse event reports

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

  • InjuryJun 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2014, THE JRNY NI TIBIAL BASE LM/RL SZ 2 LOOSENED AND THEN COLLAPSED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 WHERE THE SURGEON CONVERTED THIS PATIENT'S KNEE TO A PRIMARY TKA. THE PATIENT LEFT SURGERY IN GOOD HEALTH, BUT CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Inadequate Osseointegration

    MAUDE report 17086756 ↗
  • InjuryAug 1, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    REVISION SURGERY WAS PERFORMED DUE TO TIBIAL FRACTURE AND BASEPLATE LOOSENING. ALL IMPLANTS WERE EXCHANGED TO LEGION.

    Patient problems: Injury

    MAUDE report 8850895 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102069, K230653. One submission often covers many models, so check the product and lot details in each record.

  • Z-2621-2023 · Aug 31, 2023 · Open, Classified
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint

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.