JOURNEY 71436133Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010588104), received between Jul 24, 2020 and Apr 19, 2023 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 15 most recent of 15 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 SZ3-4/8MM WAS NOTICED TO BE CHIPPED. 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 16772024 ↗
• InjuryJan 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKR SURGERY, THE JOURNEY UNI TIB TR INS SZ3-4/8MM DEVICE WAS FOUND TO BE BROKEN WHEN TESTING IT. THE SURGEON REMOVED ALL THE PLASTIC PIECES AND DID NOT LEAVE ANY PLASTIC PARTICLES INSIDE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY AND WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135419 ↗
• MalfunctionJan 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE POLY OF THE JOURNEY UNI TIB TR INS SZ3-4/8MM SNAPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091420 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861065 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488789 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488754 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488732 ↗
• MalfunctionApr 18, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION IN WAREHOUSE THE DEVICES WERE FOUND DEFECTIVES. THE TIBIAL SPACER BLOCK STANDAR WAS NOTICED WITH AN UNSPECIFIC FAILURE MODE ((B)(4)). THE JOURNEY FEMORAL IMPLANT IMPACTOR BUMPER RIGHT ((B)(4)) WAS NOTICED BROKEN. THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4)), UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 8 MM ((B)(4)), UNIVERSAL INSERT SPACER SIZE 1-2 13 MM ((B)(4)) AND JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 9 MM ((B)(4)) WERE NOTICED CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683500 ↗
• 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 11593430 ↗
• InjuryFeb 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING PROCEDURE ACCURIS TIBIAL INSERT HANDLE BROKE IN HALF WHILE TRYING TO PLACE INSERT. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN CHANGING THE SURGICAL TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331774 ↗
• InjuryJan 28, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE JOURNEY UNI TIB TR INS SZ3-4/8MM BROKE INSIDE THE PATIENT. THE BROKEN PIECE COULD BE RETRIEVED FROM PATIENT. NO SIGNIFICANT DELAY. NO PATIENT INJURY. THERE WAS A S&N BACK UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. 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 11242950 ↗
• 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 SZ3-4/8MM WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910941 ↗
• MalfunctionAug 10, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE UKR (NAVIO), THE BOTTOM CORNER OF THE PLASTIC OF THE INSERT WAS SNAPPED OFF OUTSIDE THE PATIENT, AFTER THE SURGEON ATTEMPTED TO MOUNT INTO THE TRIAL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387937 ↗
• MalfunctionJul 24, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE JOURNEY UNI TIB TR INS SZ3-4/8MM WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10319534 ↗
• MalfunctionJul 24, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE JOURNEY UNI TIB TR INS SZ3-4/8MM WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10319530 ↗