JOURNEY 74012416Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 03596010556684), received between Jan 3, 2019 and May 25, 2026 — classified as 23 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Break” (81 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); they may or may not involve this specific model.

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 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 6 FELL APART. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273326 ↗
• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN ON THE BACK OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089525 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE INSIDE PIECES OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 CAME APART AND FELL OUT ONTO THE BED. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873342 ↗
• MalfunctionMar 31, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 6 BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743721 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A RIGHT TKA SURGERY, THE SCREW ON BACK OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 FELL OUT. THE SCREW WAS RETRIEVED. 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 24688584 ↗
• MalfunctionFeb 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE DIAL ON THE FRONT OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 BROKE INTO THREE (3) PIECES WHEN THE SLAP HAMMER WAS USED TO PULL IT OFF FROM THE BONE SURFACE. CUTS WERE ALREADY MADE SO THERE WAS NO DELAY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268392 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component; Mechanics Altered

  IT WAS REPORTED THAT DURING SAWING ON A TOTAL KNEE SURGERY, THE ADJUSTABLE KNOB OF A JOURNEY DCF AP FEM CUT BLK 6 WAS SPINNING AND UPON EXTRACTION OF THE CUTTING BLOCK, THE ENTIRE ADJUSTABLE MECHANISM CAME APART. X-RAYS WERE TAKEN TO CONFIRM ALL THE PIECES WERE REMOVED FROM THE WOUND. ALL PIECES WERE REMOVED BY HAND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956956 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR SURGERY, A SCREW FELL OUT OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802716 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHILE MALLETING ON ONE (1) JOURNEY DCF AP FEM CUT BLK 6, THE MECHANISM BECAME LOOSE AND DISASSOCIATED FROM THE REPORTED DEVICE. ALL PIECES WERE ACCOUNTED FOR AND NO ITEMS OR PIECES WERE LEFT IN THE PATIENT. PATIENT LEFT IN GOOD HEALTH. 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 23751492 ↗
• MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 6 CAME APART WHEN IT WAS BEING REMOVED FROM THE FEMUR. THE CUTS HAD ALREADY BEEN MADE. ALL PARTS WERE RETRIEVED FROM THE WOUND BY HAND. 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 23532829 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SCREW CAME OFF OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 WHICH ALLOWED THE SPIKES TO DISASSEMBLE FROM THE BLOCK. ALL PIECES WERE REMOVED WITH FORCEPS. THERE ARE NO OPERATIVE NOTES OR X RAYS AVAILABLE. 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 23459709 ↗
• MalfunctionJun 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 6 AND ONE (1) JOURNEY DCF AP FEM CUT BLK 4 BROKE DURING IMPACTION. PIECES FELL OUTSIDE OF THE PATIENT AND ALL WERE RECOVERED. THE PROCEDURE WAS PERFORMED, 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 22304617 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE JOURNEY DCF AP FEM CUT BLK 6 DISASSEMBLED AFTER FEMUR CUTS WERE MADE AND IT WAS REMOVED FROM THE BONE; THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177528 ↗
• MalfunctionMay 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CENTER PIECE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 BROKE. 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 22115260 ↗
• MalfunctionMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE BROKE NEAR THE CENTER OF THE JOURNEY DCF AP FEM CUT BLK 6. IT IS UNKNOWN IF ANY PIECE FELL INTO THE INCISION. 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 22054043 ↗
• MalfunctionApr 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER MAKING THE CHAMFER CUTS WHEN THE SLAP HAMMER WAS USED TO EXTRACT THE BLOCK, A PIECE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 BROKE OFF. 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 21807317 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 BROKE OFF WHILE BEING EXTRACTED WITH BACKSLAP. NO PIECES FELL INSIDE THE WOUND. 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 21748913 ↗
• MalfunctionMar 21, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 6 BROKE WHILE EXTRACTING AFTER ALL CUTS WERE MADE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. A TWEEZERS WAS USED FOR ONE PIECE OTHERWISE THEY WERE JUST TAKEN OUT BY HAND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662085 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA, THE SCREW OF A (1) JOURNEY DCF AP FEM CUT BLK 6 CAME OUT. 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 21401814 ↗
• MalfunctionDec 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, A (1) JOURNEY DCF AP FEM CUT BLK 6 DISASSEMBLED. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE, BUT IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036321 ↗
• MalfunctionDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FRONT KNOB ON A JOURNEY DCF AP FEM CUT BLK 6 FRACTURED AFTER REMOVING FROM BONE. NO PIECES FELL INTO 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 21036278 ↗
• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 6 BROKE IN PIECES UPON BACK SLAP.THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO BROKEN PIECES FELL INSIDE THE WOUND AND PIECES WERE RETRIEVED USING TWEEZERS. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20984585 ↗
• MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE SPIKES CAME OFF THE BACK OF ONE (1) JOURNEY DCF AP FEM CUT BLK 6 WHEN REMOVING IT WITH THE SLAP HAMMER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872777 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, A (1) JOURNEY DCF AP FEM CUT BLK 6 HAD A SCREW MISSING. 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 20833138 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 6 IS BROKEN. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819127 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a