JOURNEY 74025632Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556422595), received between Jul 24, 2018 and Dec 31, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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.

• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT'S KNEE WAS UNCOMFORTABLE. A REVISION SURGERY TOOK PLACE TO EXCHANGE A JOURNEY II INSERT. IT IS UNKNOWN HOW THE PATIENT IS DOING AFTER TREATMENT.

  Patient problems: Pain

  MAUDE report 11100114 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT WAS HOSPITALIZED DUE TO A FALL. THE PATIENT SUFFERED FROM WOUND DEHISCENCE DUE TO THE FALL AND SPENT 10 DAYS IN THE HOSPITAL.

  Patient problems: Injury

  MAUDE report 9832147 ↗
• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A FALL WITH WOUND DEHISCENCE.

  Patient problems: Injury

  MAUDE report 8892472 ↗
• InjuryAug 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH ELIQUIS DUE TO LOWER EXTREMITY DEEP VEIN THROMBOSIS.

  Patient problems: Swelling

  MAUDE report 8886070 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WITH DECREASED RANGE OF MOTION AND KNEE PAIN. MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2018 TO RESOLVE THIS ISSUE.

  Patient problems: Fibrosis

  MAUDE report 8834717 ↗
• InjuryAug 31, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF TOTAL RIGHT KNEE ARTHROPLASTY. EVENT TREATMENT INCLUDED MANIPULATION UNDER ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 7837778 ↗
• InjuryJul 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE INSERT WAS REPLACED TO NEW ONE.

  Patient problems: Unspecified Infection

  MAUDE report 7715133 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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