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JOURNEY 74026159Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK XLPE TIBIA INSERT MEDIAL SIZE 3-4 9MM · Class 2 · Implant

All models of JOURNEY (566)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556677070), received between Sep 20, 2023 and Sep 20, 2023 — classified as 1 injury.

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

Patient problems

  • Medical device site infection1

Recent adverse event reports

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

  • InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN, SWELLING AND SUSPECTED INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE PATIENT EXPERIENCED DEBRIDEMENT AND THE JOURNEY II UK TIB INSRT MED SZ 3-4 9MM WAS EXCHANGED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Medical device site infection

    MAUDE report 17781799 ↗

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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