JOURNEY 74029253Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556174913), received between Jul 24, 2019 and Nov 21, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON STATED THAT THE INSERT SWAPPED OUT IN CONJUNCTION WITH PATELLA COMPONENT SWAP. THERE WAS NO DELAY NOR INJURY REPORTED. A SMITH AND NEPHEW BACKUP WAS USED.

  Patient problems: Injury

  MAUDE report 9359322 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED HYPOXEMIA POST OPERATIVE WHICH REQUIRED HOSPITALIZATION.

  Patient problems: Hypoxia

  MAUDE report 8824610 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT CELLULITIS WAS PRESENTED BY PATIENT POST OPERATIVE.

  Patient problems: Cellulitis

  MAUDE report 8824526 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST OPERATIVE HYPOTENSION REQUIRED HOSPITALIZATION AS RESULT OF THE EVENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8824431 ↗

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