JOURNEY 74012419Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 03596010556714), received between Feb 13, 2019 and Dec 11, 2025 — classified as 7 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PRIMARY TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 9 HAD A LOOSE PIECE THAT MAY FALL OFF COMPLETELY. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783306 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 9 HAD A PIECE OF METAL FRACTURE OFF WHEN CUTTING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710600 ↗
• MalfunctionMay 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY WHILE CUTTING THROUGH THE CUTTING SLOTS, A SECTION OF ONE (1) JOURNEY DCF AP FEM CUT BLK 9 FELL OFF. IT WAS EASILY RETRIEVED OUTSIDE OF THE PATIENT, AND NO ADDITIONAL PIECES BROKE OFF. REMAINDER OF NECESSARY CUTS WERE EASILY COMPLETED WITHOUT THIS PIECE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999974 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE CUTTING THE CHAMFERS WITH A JOURNEY DCF AP FEM CUT BLK 9, A METAL PIECE FELL OUT OF THE BLOCK. 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 21091981 ↗
• MalfunctionSep 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY DCF AP FEM CUT BLK 9 BROKE STRAIGHT THROUGH THE NUMBER 2 SLOT WHEN IMPACTING. IT IS UNKNOWN AT THIS TIME IF PIECES FELL INTO PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118489 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE ANTERIOR CUT SLOT OF A JOURNEY DCF AP FEM CUT BLK 9 SNAPPED OFF WHEN REMOVING SAW BLADE. BROKEN PIECE WAS REMOVED BY HAND, NO PIECES REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED, 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 19759299 ↗
• MalfunctionMay 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT, THE SMALL PIECE OF THE JOURNEY DCF AP FEM CUT BLK 9 BROKE OFF DURING IMPACTING. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19420790 ↗
• MalfunctionFeb 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 9 BROKE, THE IMPACTION PART OF THE BLOCK CHIPPED OFF. THE PIECE WAS RECOVERED. 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 18763714 ↗
• MalfunctionFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, A PIECE OF THE CHAMFER ON THE JOURNEY DCF AP FEM CUT BLK 9 BROKE OFF AND FELL ON THE FLOOR. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692499 ↗
• MalfunctionAug 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE CHAMFER PART IN ONE (1) JOURNEY DCF AP FEM CUT BLK 9 BROKE OFF. 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 17614483 ↗
• MalfunctionAug 3, 2023Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 9 WAS FOUND CRACKED AND CHIPPED. IT NO LONGER WORKS. 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 17450432 ↗
• MalfunctionFeb 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, PART OF ONE (1) JOURNEY DCF AP FEM CUT BLK 9 BROKE OFF WHILE IMPACTING IT ON THE DISTAL FEMUR. IT FELL ON THE TABLE AND WAS EASILY RETRIEVED. NO PARTS FELL IN THE WOUND. 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 16432471 ↗
• MalfunctionJul 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE SPEED PIN ON A JOURNEY FEMORAL CUTTING BLOCK SIZE 9 GOT STUCK IN THE PIN HOLE, CAUSING BURN MARKS AND DEBRIS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090397 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A JOURNEY DCF AP FEM CUT BLK 9 BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008827 ↗
• MalfunctionMar 26, 2022Break; Break

  IT WAS REPORTED THAT A JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 9 IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925098 ↗
• MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SCREW OF A JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 9 WAS FOUND TO BE MISSING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636658 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT THE METAL PIECE OF A JOURNEY FEMORAL CUTTING BLOCK SIZE 9 BROKE OFF. AS THIS HAPPENED IN A BIOSKILLS LABORATORY/MARKETING DEMONSTRATION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214455 ↗
• InjuryJan 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A PIECE OF BLOCK CRACKED OFF INSIDE THE PATIENT. SURGERY 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 13180946 ↗
• InjuryOct 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE JOURNEY DCF AP FEM CUT BLK 9 BROKE OFF WHILE CUTTING. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662630 ↗
• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT THE METAL PIECE OF A JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 9 BROKE OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605550 ↗
• InjurySep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A PART OF A JOURNEY DCF AP FEM CUT BLK 9 BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539800 ↗
• MalfunctionAug 25, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE JOURNEY DCF AP FEM CUT BLK 9 CAME OUT OF BLOCK AND NEEDS TO BE REPLACED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367685 ↗
• MalfunctionJul 20, 2021Fracture; Defective Device; Fracture; Defective Device

  IT WAS REPORTED THAT THE JOURNEY DCF AP FEM CUT BLK 9 IS NOT PASSING CENTRAL PROCESSING DEPARTMENT STANDARDS. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED. THE INVESTIGATION FOUND THAT THE FLANGES ON THE ATTACHMENT POST FRACTURED OFF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196795 ↗
• MalfunctionJun 11, 2021Crack; Connection Problem; Crack; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, A JOURNEY DCF AP FEM CUT BLK 9 WAS CLOSED DOWN AND HAD SMALL CRACKS ON BOTH SIDES OF THE BLOCK, THIS CAUSED THAT THE CUTS WERE NOT PERFECT AND THE FEMORAL TRIAL WOULD NOT FIT ON PROPERLY. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY AND IT WAS NECESSARY TO CHANGE THE SURGICAL TECHNIQUE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988123 ↗
• InjuryMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK BROKE, WHEN IT WAS BEING IMPACTED ON TO THE FEMUR INSIDE THE PATIENT. THE BROKEN PIECE WAS RECOVERED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. DESPITE THE FACT, THIS INCIDENT OCCURRED INSIDE THE PATIENT, NO HARM, INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816097 ↗