JOURNEY 74025633Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556422588), received between Apr 6, 2017 and Nov 21, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT WAS FEELING INSTABILITY IN KNEE. A REVISION SURGERY WAS PERFORMED AND THE JOURNEY II CR INSERT XLPE RIGHT SIZE 3-4 11MM WAS EXPLANTED, A SIZE 3-4 15 MM DEEP DISH RIGHT POLY WAS IMPLANTED TO HELP WITH STABILITY. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 15838593 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE LEFT INSERT WAS IMPLANTED INTO A RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8034064 ↗
• InjuryApr 6, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND LAXITY.

  Patient problems: Injury; Pain

  MAUDE report 6465241 ↗

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