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JOURNEY 74029232Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II BCS CONSTRAINED ARTICULAR INSERT SIZE 3-4 RIGHT 10MM · 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 00885556174463), received between Oct 1, 2018 and Aug 7, 2020 — classified as 2 injuries.

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

3 other recalls cover devices cleared under the same FDA submission (K140555, 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

  • Appropriate Device Problem Term/Code Not Available1
  • Break1

Patient problems

  • Failure of Implant1
  • Injury1
  • Necrosis Of Flap Tissue1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryAug 7, 2020Break; Break

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN POST. ONLY THE INSET WAS REMOVED AND A TALL POST INSERT WAS IMPLANTED. THE PATIENT OUTCOME WAS UNKNOWN.

    Patient problems: Failure of Implant; Injury

    MAUDE report 10382699 ↗
  • InjuryOct 1, 2018Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE PATIENT WENT TO A KNEE ASPIRATION DUE TO INFECTION FOLLOWING REVISION SURGERY. GROSS PURULENCE WITH SINUS TRACT THROUGH THE QUADRICEPS. NECROTIC TISSUE WAS FOUND. ONLY THE INSERT WAS REMOVED. SMALLER INSERT WAS IMPLANTED.

    Patient problems: Necrosis Of Flap Tissue; Unspecified Infection

    MAUDE report 7924320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555, K230653. One submission often covers many models, so check the product and lot details in each record.

  • Z-0157-2024 · Sep 27, 2023 · Open, Classified
    JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
  • 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-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, 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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