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JOURNEY 74034211Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II BCS CONSTRAINED INSERT TRIAL SIZE 1-2 9MM RIGHT · Class 2 · Implant

All models of JOURNEY (566)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556002698), received between Mar 26, 2022 and Mar 26, 2022 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K140555); 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

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 26, 2022Break; Break

    IT WAS REPORTED THAT, A JRNY II BCS CONST ISRT TRL S1-2 9MM RT BROKE IN HALF. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13925092 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555. 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

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

How reports and recalls are matched · Editorial policy · Report an error on this page