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JOURNEY 74024217Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II BCS FEMORAL COCR RIGHT SIZE 7 · Class 2 · Implant

All models of JOURNEY (566)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556170960), received between Jul 24, 2019 and Jul 24, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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

  • Insufficient Device Problem Information3

Patient problems

  • Cellulitis1
  • Hypoxia1
  • Low Blood Pressure/ Hypotension1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT PRESENTED HYPOXEMIA POST OPERATIVE WHICH REQUIRED HOSPITALIZATION.

    Patient problems: Hypoxia

    MAUDE report 8824636 ↗
  • InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT CELLULITIS WAS PRESENTED BY PATIENT POST OPERATIVE.

    Patient problems: Cellulitis

    MAUDE report 8824506 ↗
  • InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT POST OPERATIVE HYPOTENSION REQUIRED HOSPITALIZATION AS RESULT OF THE EVENT.

    Patient problems: Low Blood Pressure/ Hypotension

    MAUDE report 8824391 ↗

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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