JOURNEY 74023252Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010555144), received between Apr 25, 2017 and Dec 12, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2014, THE PATIENT HAD MOVEMENT RESTRICTIONS DUE TO A BROKEN (1) JOURN ART INS BCS STD 5-6 RT10. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024 IN WHICH THE JOURN ART INS BCS STD 5-6 RT10 WAS EXPLANTED AND CHANGED. PATIENT IS RECOVERING WITH NO ABNORMALITIES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 20914426 ↗
• InjurySep 23, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT, A KNEE REVISION WAS CARRIED OUT ON (B)(6) 2024 TO REVISE A JOURN ART INS BCS STD 5-6 LT 9 DUE TO A UNKNOWN ADVERSE EVENT. IT IS UNKNOWN WHEN THE PRIMARY SURGERY WAS PERFORMED. FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20285969 ↗
• InjuryAug 4, 2023Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND A JOURN ART INS BCS STD 5-6 RT10 BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT.

  Patient problems: Failure of Implant; Fall

  MAUDE report 17466770 ↗
• InjuryMay 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A SIMULTANEOUS BILATERAL TKA HAD BEEN PERFORMED ON (B)(6)2010, THE PATIENT EXPERIENCED A POST FRACTURE OF THE TIBIAL INSERT IN ONE OF THE KNEES. DUE TO THIS INCIDENT, AN EMERGENCY REVISION SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE. THE IDENTITY OF THE EXPLANTED DEVICES AND OF THE DEVICES IMPLANTED IN EXCHANGE DURING THIS PROCEDURE ARE UNKNOWN AT THIS TIME. THE PATIENT WANTS A REVISION OF THE OTHER KNEE TIBIAL INSERT, ALTHOUGH NO APPARENT ADVERSE EVENT/MALFUNCTION HAS BEEN REPORTED WITH THIS PROSTHESIS. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14548491 ↗
• InjuryDec 16, 2020Break; Break

  IT WAS REPORTED THE REVISION SURGERY WAS PERFORMED DUE TO POST WAS FRACTURED. UNKNOWN WHEN THE INCIDENT OCCURRED, AND HOW THE PROCEDURE FINISHED. NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11016755 ↗
• InjuryOct 30, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. THE REVISION SHOWED THAT THE POST ON THE INSERT BROKE AND WAS CHANGED WITH A NEW INSERT.

  Patient problems: Failure of Implant

  MAUDE report 10760034 ↗
• InjuryAug 25, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT HAD A JOURNEY ART INSERT BCS STANDARD 5-6 RIGHT10 IMPLANTED AROUND 10 YEARS AGO AND A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT WAS COMPLAINING OF DISCOMFORT AND INSTABILITY. WHEN GOING TO REMOVE THE JOURNEY ART INSERT BCS STANDARD 5-6 RIGHT10, IT WAS NOTICED THAT THE INSERT'S POST HAD BEEN SHEARED OFF. THE BROKEN INSERT WAS REMOVED AND REPLACED BY A NEW IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 10451301 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY FOR THE RIGHT KNEE AND DISLOCATION OF INSERT FOLLOWING FALL.

  Patient problems: Joint Dislocation

  MAUDE report 7444534 ↗
• InjuryFeb 5, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BROKEN INSERT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7241716 ↗
• InjuryApr 25, 2017Break; Break

  IT WAS REPORTED A POLY EXCHANGE REVISION SURGERY WAS PERFORMED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 6520570 ↗

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-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
• 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-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