JOURNEY 74024841Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010554567), received between Jul 21, 2017 and Oct 4, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED LOOSENING OF THE JRNY BCS PAT RESRF RD 41 MM STD. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JRNY BCS PAT RESRF RD 41 MM STD WAS EXCHANGED. NO DELAY REPORTED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15535497 ↗
• InjuryMar 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT COMPLAINED OF PAIN. A REVISION SURGERY WAS CONDUCTED TO ADDRESS THIS EVENT: THE SURGEON NOTICED THAT THE PATELLA WAS LOOSE AND THE KNEE WAS ALSO MEDIALLY LOOSE. THE PATELLA WAS BONE-GRAFTED AND A NEW THICKER INSERT WAS IMPLANTED. THE PATIENT¿S CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11449982 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SYNCOPE AFTER SURGERY. HOSPITALIZATION WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9356592 ↗
• InjuryApr 2, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED RIGHT PATELLAR BURSITIS LOOSENED MIGRATED PATELLAR COMPONENT.

  Patient problems: Injury

  MAUDE report 7388233 ↗
• MalfunctionSep 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD FRACTURED LEFT KNEE PATELLA AS A RESULT OF TRAUMA. IT WAS REPORTED THAT ACTION TAKEN TO SOLVE THIS PROBLEM WAS A SURGICAL PROCEDURE, BUT ALSO THAT THIS PATIENT HAS NOT HAD REVISION SURGERY OF THE LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6840868 ↗
• InjuryAug 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH LEFT KNEE SYNOVITIS AND PAIN AND WAS ADMINISTERED PREDNISONE.

  Patient problems: Inflammation; Pain

  MAUDE report 6773027 ↗
• InjuryJul 21, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A LEFT KNEE REVISION SURGERY WAS PERFORMED DUE TO PATELLA MECHANICAL LOOSENING AND PAIN.

  Patient problems: Pain

  MAUDE report 6734262 ↗

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-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