JOURNEY 74033643Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556421901), received between Jul 30, 2021 and Mar 24, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA, ONE (1) JRNY II CR ISRT TRL LT SZ 3-4 11M BROKE FROM OVERUSE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676885 ↗
• InjuryJun 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A JRNY II CR ISRT TRL LT SZ 3-4 11M BROKE WHILE INSIDE THE PATIENT. THE PIECES WERE RETRIEVED WITH A FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655076 ↗
• MalfunctionOct 4, 2021Break; Break

  IT WAS REPORTED THAT ONE JRNY II CR ISRT TRL LT SZ 3-4 11M HAD A CHIP ON IT, PROBABLY CAUSED BY OVER USE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573819 ↗
• InjuryJul 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, THE SURGEON STRUCK A JRNY II CR ISRT TRL LT SZ 3-4 11M WITH A MALLET, AND A PIECE BROKE OFF INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. AL PIECES WERE RECOVERED AND THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250830 ↗