JOURNEY 74023265Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010555243), received between Apr 9, 2021 and Jun 2, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, 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.

• InjuryJun 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON 2014}, THE PATIENT EXPERIENCED INSTABILITY AND A BREAKAGE OF THE POST OF THE (1) JOURN ART INS BCS STD 5-6 LT15. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) JOURN ART INS BCS STD 5-6 LT15 WAS REPLACED WITH A NEW ONE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 22123582 ↗
• InjuryDec 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED THAT THE POST OF A JOURNEY ARTICULAR INSERT BCS STANDARD 5-6 LEFT 15MM BROKE OFF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO ADDRESS THIS COMPLICATION. ADDITIONAL DETAILS ABOUT THIS PROCEDURE ARE UNKNOWN. PATIENT CURRENT HEALTH STATUS IS ALSO UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15963512 ↗
• InjuryAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON 2009 ON THE LEFT SIDE. A BILATERAL REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, DUE TO THE JOURN ART INS BCS STD 5-6 LT15 BROKE. THE CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15266716 ↗
• InjuryApr 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AFTER THE PATIENT SUFFERED A FALL. THE JOURNEY ARTICULAR INSERT BCS STD 5-6 15MM LEFT WAS REVISED AND EXPLANTED SINCE DURING SURGERY IT WAS DISCOVERED THAT THE INSERT POST HAD A SMALL FRACTURE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Laxity

  MAUDE report 11644170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, 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
• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112