JOURNEY 74016424Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556692264), received between Apr 25, 2021 and Nov 3, 2025 — classified as 2 injuries, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A UKA SURGERY THE PLASTIC OF ONE (1) JRNY II UNI FEMORALTRIAL HOLDER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459988 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING A UKA SURGERY, THE PLASTIC OF ONE (1) JRNY II UNI FEMORALTRIAL HOLDER WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407610 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKR (NAVIO) SURGERY, THE HANDLE OF ONE (1) JRNY II UNI FEMORALTRIAL HOLDER BROKE UPON THE IMPACTING OF THE FEMORAL COMPONENT. ALL PIECES WERE RETAINED OR REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356865 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE JRNY II UNI FEMORALTRIAL HOLDER HANDLE BROKE/FRACTURED AT THE NECK. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY AND IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407706 ↗
• InjuryNov 9, 2021Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN ON SIDE OF JOURNEY II UNI FEMORALTRIAL HOLDER HOLDING THE SPRING LOADED CLAMPS TO THE SIZE OF THE IMPACTOR FELL OUT. THE HOOK, SPRING AND PIN WERE ALL RECOVERED FROM THE PATIENT WITH TWEEZERS AND FINGERS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780026 ↗
• InjuryApr 25, 2021Break; Break

  IT WAS REPORTED THAT THE KNOB OF THE JRNY II UNI FEMORALTRIAL HOLDER THAT TIGHTENS TO IMPLANT SNAPPED ((B)(4)) AND THE BUMPER CRACKED UPON IMPACTION ((B)(4)). THESE EVENTS OCCURRED DURING USE, WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICES. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722110 ↗