JOURNEY 74023243Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010555083), received between Jul 18, 2018 and Dec 28, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY ARTICULAR INSERT BCS STANDARD 3-4 LEFT 11MM IS CRACKED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101665 ↗
• InjuryNov 25, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURN ART INS BCS STD 3-4 LT11 WAS FOUND BROKEN. THIS WAS NOTICED WHILE INSTRUMENTS WERE INSIDE PATIENT. SURGERY WAS COMPLETED REMOVING THE PIECES WITH A PAIR OF SURGICAL GRABBERS, WITHOUT ANY DELAY ,WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875255 ↗
• InjuryFeb 21, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE LINER DUE TO ANTERIOR-POSTERIOR INSTABILITY.

  Patient problems: Injury

  MAUDE report 8359362 ↗
• InjuryJul 18, 2018Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUR TO DISLOCATION. POLY WAS REPLACED.

  Patient problems: Injury; Joint Dislocation; No Code Available

  MAUDE report 7699210 ↗

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-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