JOURNEY 74021442Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556785478), received between Oct 9, 2025 and Oct 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryOct 9, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A DISASSOCIATION OF THE JII MD XLPE ART ISRT SZ 3-4 RT 10MM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JII MD XLPE ART ISRT SZ 3-4 RT 10MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23253488 ↗