JOURNEY 74023284Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010555373), received between Jun 26, 2018 and May 21, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT HAD A DISLOCATION AND THE JOURN ART INS BCS STD 7-8 LT13 POST WAS BROKEN. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11863161 ↗
• InjuryNov 4, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PATIENT SHOWED INSTABILITY WAS BROUGHT TO THE OPERATING ROOM AND THE POST IN A 7-8 LEFT 15MM JOURNEY L BCS POLY WAS BROKEN OR WORN OFF . A NEW 15MM HI POST REVISION POLY WAS PUT IN.

  Patient problems: Failure of Implant; Injury; Joint Laxity

  MAUDE report 10789376 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE POST WAS FOUND BROKEN. ALL PIECES WERE REMOVED FROM THE PATIENT. NO CONFIRMATION OF DELAY HAS BEEN RECEIVED. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719986 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. PATIENT PRESENTED WITH METALLOSIS, JOINT WAS INFLAMED, SOFT TISSUE HAD A BLACK COLOUR. THE SURGEON REVISED THE KNEE, TOOK OUT THE IMPLANTS AND REPLACED THEM.

  Patient problems: Injury

  MAUDE report 8175536 ↗
• 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 7638673 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, 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-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
• 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