JOURNEY 74023256Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010555182), received between Jun 12, 2018 and Mar 29, 2022 — 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.

• InjuryMar 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED BREAKAGE OF THE JOURNEY ARTICULAR INSERT STANDARD 5-6 RIGHT 18MM. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13939480 ↗
• InjuryMay 2, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO AN INSERT BREAKAGE.

  Patient problems: Injury

  MAUDE report 8574129 ↗
• InjuryJun 12, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. SURGEON NOTICED THAT THE POLY BEING EXPLANTED WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 7591429 ↗

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-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