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JOURNEY 71422366Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY UNI COCR FIXED BEARING FEMORAL SIZE 6 LEFT MEDIAL/RIGHT LATERAL · Class 2 · Implant

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 03596010627490), received between Apr 7, 2019 and Mar 15, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K073175, K081351, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection2
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A REVISION SURGERY WAS PERFORMED (B)(6) 2019 DUE TO AN UNSPECIFIED INFECTION WHERE THE INSERT WAS EXCHANGED. THE JOURNEY II UNICOMPARTMENTAL SYSTEM WAS CONVERTED TO A TKA ON (B)(6) 2020 DUE TO UNSPECIFIED REASONS. THE OUTCOME OF THIS PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED RETROSPECTIVELY; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

    Patient problems: Insufficient Information

    MAUDE report 16546470 ↗
  • InjuryApr 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT HAS A POSTOPERATIVE INFECTION. THE CUSTOMER WANTS TO CHECK THE STERILITY OF THE DEVICE.

    Patient problems: Unspecified Infection

    MAUDE report 8490084 ↗
  • InjuryApr 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A POSTOPERATIVE INFECTION. THE CUSTOMER ASKS IS TO CHECK THE LOT REGARDING STERILITY.

    Patient problems: Unspecified Infection

    MAUDE report 8490063 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073175, K081351, K230653. One submission often covers many models, so check the product and lot details in each record.

  • 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, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.