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JOURNEY 74033613Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II CR INSERT TRIAL RT SZ 1-2 11MM · Class 2

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 00885556422007), received between Feb 8, 2021 and Feb 8, 2021 — classified as 1 malfunction.

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

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.

  • MalfunctionFeb 8, 2021Break; Break

    IT WAS REPORTED THAT DURING TKA PROCEDURE THE JRNY II CR ISRT TRL RT SZ 1-2 11M BROKE. THIS HAPPENED DURING USE OUTSIDE THE PATIENT, NO PIECES FELL INSIDE THE WOUND. ALL PIECES RECOVERED. THERE WAS NO DELAY. HAD BACK UP. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11291247 ↗

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

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Sources and updates

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