JOURNEY 74029221Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556175415), received between Jun 19, 2025 and Nov 3, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 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 (B)(6) 2025, THE PATIENT EXPERIENCED A TEAR IN THE LATERAL COLLATERAL LIGAMENT WHICH CAUSED THAT THE CAM PART OF THE FEMORAL COMPONENT HAD OVERRIDDEN THE POST PART OF THE INSERT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY II BCS CNSTRD ART ISRT 1-2 LT 9M WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Damage to Ligament(s); Failure of Implant

  MAUDE report 23450817 ↗
• InjuryJun 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2024, A FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SINKING OF THE TIBIAL BASEPLATE AND DISCOMFORT ((B)(4)). A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO FEELING OF "WRONGNESS" AND POSTERIOR DISLOCATION OF TIBIA. THE JRNY II BCS CNSTRD ART ISRT 1-2 LT 9M WAS REPLACED FOR A JOURNEY II DEEPDISH INSERT. SURGEON MENTIONED THAT THE PATIENT HAD STIFF JOINTS AND FLEXION CONTRACTURE. WHEN BENDING THE KNEE, THE HAMSTRINGS PUSHED THE TIBIA BACKWARD AND THE FEMUR FORWARD, CAUSING DISLOCATION. THE SURGEON DOESN'T THINK PRODUCTS FAILURE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 22288802 ↗

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