JOURNEY II XR 74014533Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556242391), received between Apr 3, 2019 and Aug 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336550 ↗
• MalfunctionApr 3, 2019Break; Break

  IT WAS REPORTED THAT THE PLASTIC PIECE OF THE INSTRUMENT BROKE ON THE LAST IMPACTION SO BACKUP NEEDED. NOTHING LEFT IN THE PATIENT, NO INJURIES OR DELAYS REPORTED. . NO INJURIES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479460 ↗