JOURNEY 74029243Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556176115), received between Sep 2, 2022 and Jun 5, 2025 — classified as 2 injuries.

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.

• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH ANTIBIOTICS WERE SUPPLIED, AND ONE (1) JRNY II BCS CNSTRD ART ISRT 3-4 LT 11M WAS REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22155444 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED, THE PATIENT EXPERIENCED GLOBAL LAXITY IN THE KNEE. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO THREAD THIS ADVERSE EVENT WHERE THE JRNY II BCS CNSTRD ART ISRT 3-4 LT 11M WAS REPLACED WITH A 15MM BCS INSERT WITH EXCELLENT BALANCE AND ROM. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Joint Laxity

  MAUDE report 15349039 ↗

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