JOURNEY 74025742Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556097663), received between Jul 28, 2020 and Jul 21, 2022 — 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 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 PRESENTED WITH A STIFF KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, THE SCAR TISSUE WAS REMOVED AND THE JRNY II ISRT XLPE DD LT SZ 3-4 10MM WAS EXCHANGED FOR A NEW 3-4 9MM LEFT DISHED JOURNEY LL POLY WAS INSERTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 15072241 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFER FROM AN ACUTE RENAL FAILURE ON (B)(6) 2018 REQUIRING PROLONGED HOSPITALIZATION. RESOLVED (B)(6) 2018 AND DISCHARGED HOME ON (B)(6) 2018. EVENT WAS CONFIRMED BY LABORATORY DATA THROUGH BASIC METABOLIC PANEL. EVENT WAS TREATED WITH MEDICATION. ALSO, PATIENT PRESENTED CONFUSION 4 DAYS AFTER SURGERY, THE OUTCOME IS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10335977 ↗

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