JOURNEY 74012418Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 03596010556707), received between Feb 5, 2019 and Apr 28, 2026 — classified as 11 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Break” (49 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE. ALL THE BROKEN PIECES WERE RETRIEVED FORM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE AS THE FEMUR CUTS WERE ALREADY DONE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017231 ↗
• MalfunctionApr 14, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A JOURNEY DCF AP FEM CUT BLK 8 WAS BROKEN. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED OR IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873592 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT, DURING A LEFT TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 FRACTURED AT THE FRONT WHILE BEING RETRIEVED USING A SLAP HAMMER FOLLOWING COMPLETION OF THE 4-IN-1 FEMORAL CUTS. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454472 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE REMOVAL CAPTURE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 8 WAS FOUND TO BE BROKEN. NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23461665 ↗
• MalfunctionSep 30, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE DURING IMPACTION. SLAP HAMMER DOES NOT WORK WITH BLOCK ANYMORE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23182052 ↗
• MalfunctionSep 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) JOURNEY DCF AP FEM CUT BLK 8 WAS DAMAGED DURING IMPACTING, IT FRACTURED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073041 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BOTTOMS SCREW AND SPRING OF ONE (1) JOURNEY DCF AP FEM CUT BLK 8 FELL LOOSE. NO METAL WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004514 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, UPON REMOVING ONE (1) JOURNEY DCF AP FEM CUT BLK 8 WITH THE SLIDE HAMMER, THE WINGLETS ON THE CUTTING BLOCK THAT THE SLIDE HAMMER GRABS BROKE OFF. IT IS NOW UNABLE TO BE REMOVED VIA SLIDE HAMMER BECAUSE THE ATTACHMENT POINTS ON THE CUTTING BLOCK ARE GONE. ALL PIECES WERE ACCOUNTED FOR AND THIS INCIDENT DID NOT AFFECT THE SURGERY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710628 ↗
• MalfunctionMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE IMPACTOR KNOB OF ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE OFF DURING IMPACTION. 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 22053783 ↗
• MalfunctionApr 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 WAS CHIPPED AFTER IMPACT. 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 21827505 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE CENTER CLEAT OF A JOURNEY DCF AP FEM CUT BLK 8 BROKE DURING REMOVAL. 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 21688245 ↗
• MalfunctionMar 6, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 DISASSEMBLED DURING EXTRACTION FROM KNEE FOLLOWING CUT. THE PROCEDURE WAS COMPLETED, 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 21543037 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE PART OF THE JOURNEY DCF AP FEM CUT BLK 8 THAT SLAP HAMMER ATTACHES TO BROKE OFF WHILE SLAPPING THE FEMUR. IT DID NOT FALL INTO THE WOUND AND THE PATIENT WASN'T HARMED AND CASE WASN'T AFFECTED. THE PROCEDURE WAS COMPLETED WITHOUT 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 21531854 ↗
• MalfunctionFeb 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE OFF NEAR THE KNOB. 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 21469251 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, ON IMPACTION DURING TKA SURGERY, A PIECE OF A JOURNEY DCF AP FEM CUT BLK 8 AROUND THE DIAL, BROKE OFF. ALL PIECES WERE RETRIEVED BY HAND. 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 19768338 ↗
• MalfunctionMay 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT, THE METAL FROM A JOURNEY DCF AP FEM CUT BLK 8 BROKE OFF DURING MALLEATING. 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 19401019 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE INTO TWO PIECES. ALL PIECES WERE REMOVED BY HAND. 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 19376846 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322519 ↗
• MalfunctionMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, USING A JOURNEY DCF AP FEM CUT BLK 8, THE EXTRACTION RIM UNDER THE ADJUSTMENT DIAL BROKE DURING EXTRACTION. THE CASE WAS COMPLETED SUCCESSFULLY AS ALL CUTS WERE COMPLETED. ALL PIECES WERE REMOVED AND ACCOUNTED. IT CAME OUT WHEN THE BLOCK WAS REMOVED AND SEPARATED ON THE BACK TABLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310917 ↗
• MalfunctionDec 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT, METAL PIECE AROUND DIAL OF ONE (1) JOURNEY DCF AP FEM CUT BLK 8 WAS BROKEN OFF. NOTHING FELL INTO THE 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 18357347 ↗
• MalfunctionNov 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE METAL PIECE THAT GOES AROUND THE DIAL OF A JOURNEY DCF AP FEM CUT BLK 8 IS BROKEN OFF, ANY PIECE FELL INSIDE THE WOUND AND WAS AND REMOVED BY HAND. 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 18166931 ↗
• MalfunctionSep 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY DCF AP FEM CUT BLK 8 BROKE WHERE EXTRACTOR MAKES CONTACT. NO PIECES FELL INTO PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675172 ↗
• MalfunctionAug 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, SURGEON IMPACTED A JOURNEY DCF AP FEM CUT BLK 8 ON THE DISTAL FEMUR AND OBSERVED THAT A SPRING CAME OUT LANDING ON THE TIBIA, THE SPRING WAS REMOVED AND RETAINED. 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 17538079 ↗
• MalfunctionJul 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, UPON REMOVAL ON A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 HAD THE METAL AROUND THE CENTER MECHANISM BROKE OFF. ALL PIECES WERE FOUND AND ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, 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 17322342 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 8 BROKE WHILE IMPACTING IT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 17302938 ↗

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