JOURNEY 74027258Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556195031), received between Mar 24, 2025 and Mar 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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.

• InjuryMar 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAKAGE OF THE POST OF THE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 21MM. PATIENT WAS LEFT IN A LARGE AMOUNT OF TIBIAL POSTERIOR SLOPE DUE TO ANATOMY AND DEFORMITY; OVER YEARS OF THE POLY POST COMING INTO CONTACT WITH POSTERIOR CAM, THE POLY FATIGUED AND BROKE. IT IS UNKNOWN HOW AND WHEN THIS ADVERSE EVENT WAS SOLVED. ALSO, PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21683753 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5