JOURNEY 74025732Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556097267), received between Jul 15, 2020 and Jul 29, 2020 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K113482, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CELLULITIS ON THE RIGHT KNEE AND LEG HAD PRESENTED. PATIENT DEVELOPED REDNESS AND SWELLING OF THE LEG. ADMITTED TO HOSPITAL FOR ANTIBIOTICS. EVENTUALLY RESOLVED WITHOUT LONG TERM PROBLEMS. HOME PHYSICAL THERAPY AND MEDICATION WERE PRESCRIBED FOR TREATMENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10339883 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE DEVICES MAY HAVE CONTRIBUTED TO CAUSE CEREBRAL VASCULAR ACCIDENT ON PATIENT. THE PATIENT NEEDED HOSPITALIZATION AND MEDICATION DUE TO THE REPORTED EVENT. PATIENT WAS GIVEN TPA, AND WAS TRANSFERRED TO PATIENT REHABILITATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Vascular System (Circulation), Impaired

  MAUDE report 10279866 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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