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JOURNEY 74024925Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II BCS FEMORAL COCR LEFT SIZE 5 · Class 2 · Implant

All models of JOURNEY (566)

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

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 00885556611432), received between Jan 19, 2018 and Oct 3, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Slipped1
  • Insufficient Device Problem Information1

Patient problems

  • Pain2

Recent adverse event reports

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

  • InjuryOct 3, 2018Device Slipped

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAIN IN THE KNEE. NO EVIDENCE OF INFECTION WAS FOUND. LAXITY OF THE COMPONENTS WAS PRESENT MOST NOTABLY IN FULL FLEXION. FEMORAL, TIBIAL AND ARTICULAR DEVICES WERE EXPLANTED.

    Patient problems: Pain

    MAUDE report 7930753 ↗
  • InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS REQUIRED TO TREAT PAIN.

    Patient problems: Pain

    MAUDE report 7206425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

  • Z-0158-2024 · Sep 27, 2023 · Open, Classified
    JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
  • Z-0157-2024 · Sep 27, 2023 · Open, Classified
    JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
  • 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
  • Z-1099-2022 · Apr 19, 2022 · Terminated
    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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