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JOURNEY 74026170Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK XLPE TIBIA INSERT MEDIAL SIZE 5-6 10MM · Class 2 · Implant

All models of JOURNEY (566)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556677155), received between Nov 27, 2020 and Mar 15, 2023 — classified as 1 injury, 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K190085, K230653, K242711); 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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Connection Problem1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 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 RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2019 TO ADDRESS A MEDIAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2020 DUE TO UNSPECIFIED COMPLICATIONS AND/OR ADVERSE EVENTS WHERE THE TIBIAL INSERT WAS EXCHANGED. 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 16550228 ↗
  • MalfunctionNov 27, 2020Connection Problem; Connection Problem

    IT WAS REPORTED THAT THE ITEM WOULD NOT LOCK DURING SURGERY, OUTSIDE THE PATIENT. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10913015 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190085, K230653, K242711. 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
  • Z-1393-2023 · Mar 27, 2023 · Open, Classified
    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
  • Z-2132-2020 · Jan 28, 2020 · Terminated
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti
  • Z-2133-2020 · Jan 28, 2020 · Terminated
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti

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

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

Sources and updates

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