JOURNEY 74024623Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010554468), received between Aug 29, 2017 and Nov 20, 2019 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AN ASPIRATION PERFORMED DUE TO CONTINUED PAIN AND SWELLING AT THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 9349495 ↗
• InjuryMay 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ARTHROSCOPY PERFORMED DUE TO PERSISTENT PAIN.

  Patient problems: Pain

  MAUDE report 8624629 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.

  Patient problems: Pain

  MAUDE report 8347911 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.

  Patient problems: Injury

  MAUDE report 8347902 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT IN 2017, PATIENT HAS PERSISTENT PAIN AND KNEE IS TURNING BLACK. PATIENT RECEIVED AN INJECTION TO TREAT THE PAIN.

  Patient problems: Pain

  MAUDE report 8294122 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT IN 2017, PATIENT HAS PERSISTENT PAIN AND KNEE IS TURNING BLACK. PATIENT RECEIVED AN INJECTION TO TREAT THE PAIN.

  Patient problems: Foreign Body Reaction; Implant Pain; Inadequate Osseointegration; Inadequate Pain Relief; Injury; Loss of Range of Motion; Pain

  MAUDE report 8223508 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE SWELLING AND STIFFNESS, RESOLVED WITH MANIPULATION UNDER ANESTHESIA; MODERATE RIGHT KNEE EFFUSION WITH NO DRAINAGE; AND RIGHT KNEE PAIN WORSENING WITH A STEROID INJECTION ORDERED.

  Patient problems: Joint Swelling

  MAUDE report 7160913 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED POST-OPERATORY PAIN. SUBJECT HAD 10 ML FLUID ASPIRATED AND RECEIVED A DEXAMETHASONE INJECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7143297 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT KNEE ARTHROSCOPY DUE TO LATERAL PATELLAR FACET PAIN AND PATELLAR CLUNK.

  Patient problems: No Code Available; Pain

  MAUDE report 6826500 ↗

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-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