JOURNEY 74023273Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010555298), received between Apr 3, 2019 and Feb 4, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (5 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.

• InjuryFeb 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON 2011, THE PATIENT EXPERIENCED SEVERAL EPISODES OF GROSS KNEE INSTABILITY IN WHICH THE SURGEON DESCRIBED AS A KNEE DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JOURN ART INS BCS STD 7-8 RT11 WAS EXCHANGED DUE TO BREAKAGE OF THE POST. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 21304010 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKA SURGERY ON (B)(6) 2024, IN WHICH ONE (1) JOURN ART INS BCS STD 7-8 RT11 WAS EXPLANTED SINCE THE SURGEON WAS IN THE JOINT SPACE ALREADY. THE POLY IN QUESTION WAS NOT DAMAGED, NOR HAD ANY ISSUES PER THE SURGEON. THERE WERE NO ISSUES WITH THE S+N IMPLANTS, INFECTION OR LOOSENING, BUT THE IMPLANT HAD BEEN IN, OVER 15 YEARS. PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 21096190 ↗
• InjuryJan 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A BROKEN POST. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2023, TO EXPLANT THE JOURN ART INS BCS STD 7-8 RT11. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16265140 ↗
• InjuryMay 10, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA, A PATIENT COMPLAINED OF PAIN. A REVISION SURGERY WAS PERFORM ON (B)(6) 2021 TO EXCHANGE THE JOURNEY ARTICULAR INSERT BCS STD 7-8 RT11 DUE TO THE POST HAD BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11798606 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, THERE WAS A REVISION SURGERY FOR A RIGHT JOURNEY BCS 7-8 11MM INSERT ON (B)(6) 2021 DUE TO A BROKEN POST.

  Patient problems: Failure of Implant

  MAUDE report 11687106 ↗
• InjuryFeb 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE POST OF A JOURNEY ART INS BCS STD 7-8 RT11 BROKE. A REVISION SURGERY WAS MADE TO EXPLANT THE BROKEN IMPLANT. THE CURRENT STATUS OF THE PATIENT'S HEALTH IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11326534 ↗
• InjuryJun 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN POST. PATIENT IS A FIT HEALTHY ACTIVE MAN. IMPLANT WAS REPLACED WITH A SIZE 7/8 11MM JOURNEY BCS INSERT. PATELLA WAS ALSO RESURFACED - SIZE 23MM JOURNEY BCS BICONVEX PATELLA. SURGEON DOES BLAME IMPLANT.

  Patient problems: Injury

  MAUDE report 10148992 ↗
• InjuryApr 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE, DURING THE REVISION THE POST WAS FOUND TO BE BROKEN. IT WAS REPLACED WITH A REVISION INSERT.

  Patient problems: Injury

  MAUDE report 8478886 ↗

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-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
• 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