JOURNEY 74022228Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010554420), received between Nov 9, 2017 and Aug 9, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID.: ORUS-JOURNEY II BCSMULTI-PMCFU; SUBJECT ID: 35005; AE NO.: AE04 IT WAS REPORTED THAT AFTER A TKR SURGERY, PERFORMED ON (B)(6) 2012, WHERE THE FOLLOWING DEVICES WERE IMPLANTED: JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 , JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 7-8 LEFT 9MM , JOURNEY TIBIAL BASEPLATE NONPOROUS LEFT SIZE 8 AND GENESIS II RESURFACING PATELLA 38MM. ON (B)(6) 2012 THE PATIENT PRESENTED A LYMPHEDEMA ON THE LEFT LEG (WHERE THE DEVICES WERE IMPLANTED), ADVERSE EVENT WAS TREATED WITH PHYSICAL THERAPY BUT WAS NOT RESOLVED. PATIENT DIED OF MYELODYSPLASTIC SYNDROME ON (B)(6) 2018, THIS DEATH CAUSE IS NOT RELATED TO THE IMPLANTED DEVICES.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12295316 ↗
• InjuryJun 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED. THE IMPLANT WAS REMOVED.

  Patient problems: Injury

  MAUDE report 7638672 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO LEFT KNEE SWELLING AND PAIN.

  Patient problems: Pain; Swelling

  MAUDE report 7016154 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, 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-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-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