JOURNEY 74026035Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556675885), received between Feb 3, 2023 and Nov 16, 2025 — classified as 2 injuries.

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

Recent adverse event reports

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

• InjuryNov 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A TIBIAL FRACTURE AND PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JOURNEY II UK OX FEM SZ 5 RM/LL, ONE (1) JOURNEY II UK MED TIB BASE SZ 3 RT AND ONE (1) JOURNEY II UK TIB INSRT MED SZ 3-4 8MM WERE EXPLANTED AND REPLACED WITH COMPETITOR IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 23565837 ↗
• InjuryFeb 3, 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 AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT REQUIRED A CONVERSION TO TKA ON AN UNKNOWN DATE DUE TO UNSPECIFIED COMPLICATIONS AND/OR ADVERSE EVENTS. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED FORTY FOUR (44) MONTHS FOLLOWING THE INDEX IMPLANTATION. 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 16300491 ↗

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