JOURNEY 74029225Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556175811), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED IN 2019, THE PATIENT FELL ON HER KNEE AND DEVELOPED A HEMATOMA 3 WEEKS AGO, WHICH BECAME INFECTED. THE INFECTION WAS DEEMED SUPERFICIAL. THE JRNY II BCS CNSTRD ART ISRT 1-2 LT 13M WAS NOT EXCHANGED, SINCE THE INFECTION DID NOT GO INTO THE JOINT. THIS ADVERSE EVENT WAS SOLVED ON (B)(6) 2025, IN WHICH THE SURGEON DISSECTED DOWN TO THE CAPSULE AND WASHED OUT EVERYTHING. PATIENT'S CURRENT HEALTH STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 21416132 ↗

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