JOURNEY 71436137Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010588142), received between Jun 23, 2020 and Apr 19, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Break; Break

  IT WAS REPORTED THAT, DURING A UKA SURGERY, A JOURNEY UNI TIB TR INS SZ5-6/8MM WAS BROKEN DURING USE, ALL THE PIECES WHERE REMOVED USING FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY; HOWEVER IT IS UNKNOWN HOW. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771994 ↗
• MalfunctionApr 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKR SURGERY, WHILE USING A JOURNEY UNI TIB TR INS SZ5-6/8MM, A PIECE OF PLASTIC BROKE FROM ITS UNDERSIDE. THE BROKEN PIECE WAS RETRIEVED WITH FORCEPS AND ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728308 ↗
• MalfunctionMar 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A UKR, WHEN USING THE JOURNEY UNI TIB TR INS SZ5-6/8MM, A PIECE OF THE PLASTIC FROM THE UNDERSIDE BROKE OFF. THE BROKEN PIECE WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655922 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593434 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT THE JOURNEY UNI TIB TR INS SIZE 5-6/8MM WAS WEDGED INTO THE HOLDING PLACE IN THE TRAY AND NOW HAS A SMALL GOUGE OUT OF THE SIDE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269617 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT THE JOURNEY UNI TIBIAL TRIAL INSERT SIZE 5-6/8MM WAS FOUND TO BE WORN, CHIPPED AND CRACKED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222092 ↗
• MalfunctionDec 11, 2020Break; Break

  IT WAS REPORTED THAT, DURING A TKA, USING A JOURNEY UNI TIB TR INS SIZE 5-6/8MM, THE PLASTIC BROKE OFF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991192 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION OF THE INSPECTED KIT # 008379-022-S002 IT WAS FOUND THAT THE JOURNEY UNI TIB TR INS SZ5-6/8MM WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911127 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10184275 ↗