JOURNEY 71436128Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010588067), received between Dec 3, 2020 and Oct 31, 2022 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE A TRIAL REDUCTION DURING UNI PROCEDURE, A JOURNEY UNI TIB TR INS SZ 1-2/8MM PIECE BROKE FROM THE MAIN BODY AND WAS THEN RETRIEVED BY FORCEPS. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. THE PROCEDURE WAS FINISHED WITH A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705353 ↗
• MalfunctionFeb 21, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A JOURNEY UNI TIB TR INS SIZE 1-2/8MM WAS WORN AND NO LONGER SLIDES INTO THE TIBIAL TRAY DUE TO WARPED EDGES. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. UPON INVESTIGATION, IT WAS FOUND THAT THE TRIAL IS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568106 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT ((B)(6)), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT ((B)(6)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(6)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT ((B)(6)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM ((B)(6)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM ((B)(6)),JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM ((B)(6)), THREE HONEYCOMB ((B)(6)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT ((B)(6)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT ((B)(6)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(6)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER ((B)(6)) AND SCREWDRIVER RELEASE HANDLE ((B)(6)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593431 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT, AFTER AN UNICONDYLAR TOTAL KNEE PROCEDURE, THE JOURNEY UNI TIB TR INS SZ 1-2/8MM WAS FOUND BROKEN. THE PATIENT WAS NOT INVOLVED AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938974 ↗