JOURNEY 74029256Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556175064), received between Jun 13, 2017 and Mar 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K140555, 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.

• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTED KNEE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JRNY II BCS CNSTRD ART ISRT RT 5-6 15M WAS REPLACED WITH THE SAME SIZE AND TYPE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 21628153 ↗
• InjuryJun 13, 2017Unstable; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TIBIAL INSERT WAS REVISED DUE TO RIGHT KNEE INSTABILITY; EXPLORATION SYNOVECTOMY AND REVISION TIBIAL INSERT. ADDITIONALLY, THIS AE REPORT COMPRISED OF TERMS: PAINFUL RIGHT KNEE TKA/RECURRENT EFFUSION (NO INFECTION)/CHRONIC INSTABILITY.

  Patient problems: Injury; Pain; Swelling

  MAUDE report 6636041 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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