JOURNEY 74029246Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556176269), received between Dec 7, 2021 and May 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INFECTION ON AN UNSPECIFIED DATE. E ADVERSE EVENT WAS ADDRESSED ON (B)(6) 2025, DURING WHICH A SURGICAL WASHOUT WAS PERFORMED AND THE (1) JRNY II BCS CNSTRD ART ISRT 3-4 LT 15M WAS REPLACED WITH A NEW INSERT OF THE SAME SIZE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22101643 ↗
• InjuryDec 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISLOCATION OF THE JRNY II BCS CNSTRD ART ISRT 3-4 LT 15M POST. THIS ADVERSE EVENT WAS SOLVED/TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A POLY SWAP WAS DONE TO CORRECT THE ISSUE. THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO DELAY, NO INJURY.

  Patient problems: Joint Dislocation

  MAUDE report 20995888 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS. THE ORIGINAL PLAN WAS A FULL REVISION OF JOURNEY II KNEE BUT INTRAOPERATIVE CHANGED PLAN TO LEAVE THE JOURNEY II BCS FEMUR AND USE A LEGION-JOURNEY LOCK DETAIL REVISION TIBIA WITH A J2 BCS CONSTRAINED INSERT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953559 ↗

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