JOURNEY 74022129Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556170618), received between Aug 28, 2017 and Nov 9, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO KNEE SWELLING AND PAIN.

  Patient problems: Pain; Swelling

  MAUDE report 7015632 ↗
• InjuryAug 28, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY DUE TO MECHANICAL LOOSENING ON THE LEFT KNEE. FOR THAT REASON PATIENT UNDERWENT REMEDIAL THERAPY (DURG/TRANSFUSION) AND SURGICAL PROCEDURE.

  Patient problems: Injury; Joint Disorder

  MAUDE report 6823351 ↗

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