JOURNEY 71422433Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556088241), received between Jul 10, 2020 and Oct 17, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K102069, 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Migration; Migration

  IT WAS REPORTED THAT, AFTER AN UKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A SINKING OF THE TIBIAL COMPONENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY UNI TIBIAL BASE RM/LL SZ 3, ONE (1) JOURNEY UNI TIBINRT S3-4RM/LL8MM AND ONE (1) JUNI OX FB FEM SZ 2 RM LL WERE EXCHANGED FOR A LEGION IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23323846 ↗
• InjuryApr 29, 2025Migration; Migration

  IT WAS REPORTED THAT, AFTER AN UNICOMPARTIMENTAL KNEE SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A PROSTHESIS MOBILIZATION DUE TO A SUSPICION OF ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 21926546 ↗
• InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2016 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 WERE ALL COMPONENTS WHERE EXCHANGE. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15358595 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO PAIN, FEVER, SWELLING, MIGRATION AND LOOSENING OF TIBIAL BASE PLATE. THE DOCTOR SAYS THE DEVICES WERE NOT DEFECTIVE. THIS WAS CAUSED BY HIGH WEIGHT OF THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Swelling; Pain

  MAUDE report 10259585 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102069, 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