JOURNEY 71422435Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556088340), received between Jun 27, 2018 and Jan 2, 2026 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A UKA PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED BY PERFORMING A TKA ON (B)(6) 2025, DURING WHICH THE JRNY UNI TIBIAL BASE RM/LL SZ 5, AND THE INSERT WERE EXCHANGED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23950340 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED WITH JOURNEY UNI ON (B)(6) 2020, THE PATIENT EXPERIENCED A PROGRESSIVE PATELLOFEMORAL ARTHRITIS. THIS EVENT WAS SOLVED BY A REVISION SURGERY, EXPLANTING THE JOURNEY UNI AND IMPLANTING THE GENESIS, ON (B)(6) 2021. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Arthritis

  MAUDE report 12250737 ↗
• InjuryJun 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TIBIA BASE WAS LOOSE AND FEMORAL THEREBY FEMORAL COMPONENT WAS SEVERELY MECHANICALLY DAMAGED.

  Patient problems: Injury

  MAUDE report 7644504 ↗

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