JOURNEY 74023263Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010555229), received between Sep 14, 2019 and Jun 30, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JOURN ART INS BCS STD 5-6 LT11 WAS REMOVED AND A DAMAGED POST WAS OBSERVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22353265 ↗
• InjuryApr 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED SEVERE LEFT KNEE PAIN FOURTEEN YEARS POST-OPERATIVE. ON (B)(6) 2024, THE PATIENT EXPERIENCED A SHARP PAIN IN HER LEFT KNEE IN THE MIDDLE OF THE NIGHT AND COULD NOT WALK VERY WELL. THE PAIN GOT A LITTLE BETTER WITH MORE MOVING, AND WAS WORSE SITTING THAN STANDING UP. PATIENT TOOK IBUPROFEN, BUT IT DID NOT HELP. ON (B)(6) 2024, THE PATIENT WOKE UP FROM A SEVERE PAIN AFTER MOVING THEIR LEGS WHILE SLEEPING, AND SHE WAS NOT ABLE TO STRAIGHTEN HER LEFT LEG AS KNEE WAS LOCKED IN A PAINFUL ANGLE. THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, WHERE THE POST OF A JOURNEY ART INSERT BCS STD 5-6 LT 11MM WAS NOTICED TO BE BROKEN. THIS IMPLANT WAS REPLACED WITH A NEW, UNKNOWN INSERT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 19130867 ↗
• InjuryDec 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY WAS CONDUCTED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN PS POST. THIS ADVERSE EVENT WAS TREATED BY A SECOND REVISION SURGERY ON (B)(6) 2023 IN WHICH THE JOURN ART INS BCS STD 5-6 LT11 WAS EXCHANGED. PATIENT WENT HOME ON DAY #1 POST-SURGERY AND IS CURRENTLY WELL.

  Patient problems: Failure of Implant

  MAUDE report 18313065 ↗
• InjuryDec 17, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY ART INS BCS STANDARD 5-6 LEFT11 WAS NOTICED BROKEN. A REVISION SURGERY WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11029564 ↗
• InjurySep 14, 2019Material Separation; Material Separation

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO POST SNAPPED OFF POLY.

  Patient problems: Injury

  MAUDE report 9058138 ↗

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