JOURNEY 74027225Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556177419), received between Oct 3, 2018 and May 29, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryMay 29, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A TKA SURGERY, A JRNY II BCS XLPE ART ISRT SZ 1-2 LT 13MM POLY WAS IMPLANTED ON (B)(6)2023 IN A SIZE THREE (3) JOURNEY TIBIA. THE MIX MATCH IMPLANT WAS NOTICED ON THE MORNING OF (B)(6)23 WHEN RESTOCKED WITH AN INVOICE. THE ISSUE WILL BE RESOLVED WITH REVISION SURGERY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017287 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE AFFECTED KNEE WAS IRRIGATED AND THE INSERT WAS REPLACED TO NEW ONE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7931629 ↗

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-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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5