JOURNEY 74023285Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010555380), received between Jun 5, 2018 and Feb 5, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K042515); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT WAS UNSTABLE AND THE POST ON THE POLY INSERT WAS BROKEN. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JOURN ART INS BCS STD 7-8 LT15 WAS EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 18640344 ↗
• InjuryJun 4, 2021Break; Break

  IT WAS REPORTED THAT AFTER A TKA SURGERY (DATE OF ORIGINAL IMPLANTATION UNKNOWN), A JOURN ART INS BCS STD 7-8 LT15 BROKE INSIDE THE PATIENT AND THERE WAS A REVISION SURGERY TO EXPLANT ON (B)(6) 2021. IMPLANT WAS REPLACED WITH A JOURNEY 1 REV INSERT AND NEW JOURNEY 35MM PATELLA.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943745 ↗
• InjuryJun 5, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURED DEVICE THAT CAUSED A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7571750 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515. One submission often covers many models, so check the product and lot details in each record.

• 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