JOURNEY 74023241Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010555069), received between Sep 6, 2018 and Dec 9, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED IN 2007, PATIENT EXPERIENCED SUDDEN INSTABILITY FROM THE KNEE. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE JOURN ART INS BCS STD 3-4 LT 9 WAS EXCHANGED DUE TO A BROKEN POST. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23756727 ↗
• InjuryNov 25, 2024Break; Break

  IT WAS REPORTED THAT, AFTER A TKA IN BOTH KNEES, THE PATIENT SUFFERED FROM BILATERAL INSTABILITY AND KNEE PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY OF THE LEFT SIDE ON (B)(6)2024 IN WHICH THE JOURN ART INS BCS STD 3-4 LT 9 WAS EXPLANTED DUE TO BROKEN AND WORN POST. IT WAS ALSO FOUND THAT THE PATIENT HAS PROGRESSION OF OSTEOARTHRITIS OF THE PATELLA. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthritis; Failure of Implant; Joint Laxity

  MAUDE report 20775590 ↗
• InjuryJul 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2007, THE JOURN ART INS BCS STD 3-4 LT 9 BROKE. THE PART WAS REPLACED ON A REVISION SURGERY PERFORMED ON (B)(6) 2024. PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19731220 ↗
• InjuryJan 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA WAS PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED AN IMPLANT FRACTURE: THE POST OF A JOURNEY ARTICULAR INSERT BCS STANDARD 3-4 LEFT 9MM BROKE OFF. THIS EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6)2023, IN WHICH THE INSERT WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18544203 ↗
• InjuryFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2006, THE PATIENT SUSTAINED JOINT AP INSTABILITY WITH A PEG FRACTURE OF THE JOURN ART INS BCS STD 3-4 LT 9. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16415094 ↗
• InjuryAug 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2008, PATIENT PRESENTED WITH ANTERIOR/POSTERIOR INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE JOURN ART INS BCS STD 3-4 LT 9 WITH A J2 CRDD OF THE SAME SIZE. UPON REVISION, THE POST OF THE JOURN ART INS BCS STD 3-4 LT 9 WAS FOUND TO BE FRACTURED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15203305 ↗
• InjurySep 30, 2019Fracture; Fracture

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

  Patient problems: Injury

  MAUDE report 9135167 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY IN WHICH THE BI-LATERAL PATELLA WAS REPLACED. AS A STANDARD THE SURGEON DOES A POLY CHANGE THEN AS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7853095 ↗

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-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