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JOURNEY 74026029Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK OXINIUM FEMORAL SIZE 9 LEFT MEDIAL/RIGHT LATERAL · 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 00885556675823), received between Oct 23, 2022 and Feb 14, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Off-Label Use1

Patient problems

  • Ambulation or Postural Difficulties1
  • Bone Fracture(s)1
  • Bursitis1
  • Inflammation1
  • Insufficient Information1
  • Pain1

Recent adverse event reports

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

  • InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A NAVIO-ASSISTED LEFT UKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022 DUE TO OSTEOARTHRITIS, THE PATIENT STARTED EXPERIENCING A PES ANSERINUS PAIN SYNDROME ON (B)(6) 2022. THE PATIENT IS UNABLE TO WALK WITHOUT AIDS. THIS ADVERSE EVENT WAS TREATED WITH MEDICATION (BUPIVACAINE AND TRIAMCINOLONE). THE PATIENT'S OUTCOME IS RECOVERING.

    Patient problems: Ambulation or Postural Difficulties; Bursitis; Inflammation; Pain

    MAUDE report 16372607 ↗
  • InjuryOct 23, 2022Off-Label Use; Off-Label Use

    IT WAS REPORTED THAT, AFTER A UKR HAD BEEN PERFORMED ON (B)(6) 2022 AN UNSPECIFIED ADVERSE EVENT OCCURRED THAT LED TO THE SYSTEM REMOVAL ON (B)(6) 2022. IT WAS AN ENGAGE SYSTEM USED WITH JOURNEY UNI OXINIUM FEMORAL COMPONENT. IT IS UNKNOWN WHAT THE CURRENT HEALTH STATUS IS.

    Patient problems: Bone Fracture(s); Insufficient Information

    MAUDE report 15656521 ↗

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-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
  • 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

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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