JOURNEY 74025614Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556422717), received between Jul 24, 2018 and Jun 15, 2020 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K121443, 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.

• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ORTHOPEDIC SURGERY HAD TO BE PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE. REHABILITATION THERAPY FOLLOWING THE TKA WITH JOURNEY II CR TKS WAS PERFORMED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 10154086 ↗
• InjuryAug 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED RIGHT TRAUMATIC ARTHROTOMY STATUS POST FALL, REMOVAL OF FOREIGN BODY AND REVISION OF POLY.

  Patient problems: Injury

  MAUDE report 8940106 ↗
• InjuryJun 10, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT SUSTAINED A TRAUMATIC FALL AT HOME WHICH RESULTED IN TRAUMATIC ARTHROTOMY OF THE KNEE. PATIENT WAS TAKEN TO SURGERY FOR IRRIGATION, DEBRIDEMENT, REMOVAL OF FOREIGN BODY, HEMATOMA AND REVISION OF POLYETHYLENE COMPONENT.

  Patient problems: Injury

  MAUDE report 8683944 ↗
• InjuryJul 24, 2018Material Deformation; Material Deformation

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. RETRIEVED INSERT SHOWED THAT THE MEDIAL SIDE DEFORMED (DAMAGED).

  Patient problems: Joint Dislocation

  MAUDE report 7716751 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, K230653. One submission often covers many models, so check the product and lot details in each record.

• 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