JOURNEY 74021123Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010554147), received between Dec 16, 2018 and Feb 19, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A COMPLETE SYNOVECTOMY WAS PERFORMED DUE TO AN HEMATOGENOUSLY SPREAD ACUTE DEEP SEPSIS AND ALL TOTAL KNEE IMPLANTS WERE REPLACED WITH IMPLANTATION OF ANTIBIOTIC IMPREGNATED SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8350792 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HAVING KNEE PAIN, REDNESS AND SWELLING, AND AN INCISION AND DRAINAGE OF THE LEFT KNEE WITH ARTHROCENTESIS WAS PERFORMED DUE TO PROXIMAL LEG ABCESS WITH SECONDARY CELLULITIS ADJACENT TO TOTAL KNEE ARTHROPLASTY.

  Patient problems: Pain; Swelling

  MAUDE report 8350773 ↗
• InjuryDec 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO PATIENT WAS DIAGNOSED WITH ARTHROFIBROSIS LEFT KNEE, STATUS POST TOTAL KNEE ARTHROPLASTY.

  Patient problems: Fibrosis; Injury

  MAUDE report 8167881 ↗

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-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-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