JOURNEY 74027214Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556178812), received between Oct 17, 2018 and Jun 22, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY II BCS XLPE ART ISRT SIZE 1-2 RIGHT 12MM ((B)(4)) AND COULD NOT BE FULLY SEATED TO JOURNEY TIBIA BASE NP RT SZ 2 ((B)(4)). THERE WAS A 15 MINUTE DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046645 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED FROM FAILURE TO PROGRESS WITH FLEXION. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 10538525 ↗
• InjuryMar 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON THE RIGHT SIDE. INSERT WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 8380870 ↗
• InjuryOct 17, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DISASSOCIATION OF PATELLA COMPONENT. THE PATELLA COMPONENT AND INSERT WERE REPLACED. NO DELAY ON THE PROCEDURE.

  Patient problems: Injury; Pain

  MAUDE report 7974736 ↗

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