JOURNEY 74025764Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556098561), received between Sep 16, 2020 and Sep 16, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K113482, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A JOURNEY II POLY WAS EXPLANTED FROM A PATIENT AS PART OF AN IRRIGATION AND DEBRIDEMENT PROCESS FOR PERIPROSTHETIC KNEE INFECTION. THE EXPLANTED POLY WAS REPLACED BY ANOTHER POLY OF THE SAME TYPE. THE POLY WAS NOT CONSIDERED TO BE THE PROBLEM. THE ORIGINAL PRIMARY TKA PROCEDURE WAS PERFORMED ON (B)(6) 2020. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10542141 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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