JOURNEY 74012415Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 03596010556677), received between Nov 19, 2018 and Aug 27, 2026 — classified as 23 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Break” (75 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 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.

• MalfunctionAug 27, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  It was reported that, during a TKA surgery, one (1) JOURNEY DCF AP FEM CUT BLK 5 had a screw on the back of the AP cutting block come out while the AP cutting block was being removed with the universal extractor tool. The screw was recovered. The surgeon also reported that two pegs on the cutting block extended through the 1 and 2 cut slots and interfered with the cutting process, preventing a complete cut from being made. 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 50488492 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304098 ↗
• MalfunctionAug 14, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255426 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  It was reported that, during a TKA, when cutting the femur, one (1) JOURNEY DCF AP FEM CUT BLK 5 had disassembled/broken down. Scrub nurse ensured central lock (dot to dot) was locked prior to handing to Surgeon. Finished the cuts but had to use a rongeur to take the parts out bit by bit. 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 50225105 ↗
• MalfunctionApr 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHILE THE SURGEON WAS USING THE JOURNEY DCF AP FEM CUT BLK 5 THE INSIDE PIECES CAME APART AND FELL OUT ONTO THE BED. 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 24787079 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 5 BROKE DURING IMPACTION. 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 24455138 ↗
• MalfunctionFeb 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 5 BLOCK CAME APART. 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 24340856 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER MAKING THE FEMORAL CUTS ONE SCREW OF ONE (1) JOURNEY DCF AP FEM CUT BLK 5 CAME OUT ALONG WITH THE BAR. NOTHING FELL IN THE WOUND. 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 24259903 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY AFTER CUTS WERE MADE, THE SCREWS OF ONE (1) JOURNEY DCF AP FEM CUT BLK 5 CAME LOOSE AND THE ENTIRE BLOCK DISASSEMBLED. THE DEVICE DIDN'T LEAVE ANY PIECES IN THE WOUND. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24013112 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SLAP HAMMER BROKE OFF THE TIP OF ONE (1) JOURNEY DCF AP FEM CUT BLK 5. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537975 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Material Deformation; Mechanical Jam; Detachment of Device or Device Component; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 5 WAS OBSERVED TO BE SOMEWHAT OFF, AND IT WAS NOTED THAT THE CENTRAL DIAL WAS SITTING HIGH. AFTER THE BLOCK WAS REMOVED, THE BACK SCREW FELL OUT AND WAS RECOVERED SAFELY. THE SCREW FELL ON TOP OF THE TIBIA AND WAS RETRIEVED WITH PICKUPS. ALL METAL FRAGMENTS WERE ACCOUNTED FOR, AND NONE WERE RETAINED IN THE PATIENT. 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 23005308 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHILE USING ONE (1) JOURNEY DCF AP FEM CUT BLK 5 TO CUT THE PATIENTS FEMUR A SMALL PIN FELL FROM THE A/P ADJUSTMENT DIAL. THE SURGEON SPOTTED THE PIN ON THE OPERATING DRAPES AND HANDED IT OUT TO THE SCRUB PRACTITIONER. THE BLOCK WAS SECURED IN PLACE WITH THREADED PINS AND THE LOSE PIN DID NOT IMPACT THE PERFORMANCE OF THE DEVICE. THE TEAM CHECKED AND CONFIRMED THE PIN WAS PART OF THE A/P ADJUSTMENT DIAL SITED ON THE FACE OF THE CUTTING BLOCK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE TO COMPLETE ALL THE CUTS. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004945 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, WHEN ONE (1) JOURNEY DCF AP FEM CUT BLK 5 WAS BEING REMOVED FROM THE FEMUR WITH THE BACK SLAP, THE MECHANICAL MECHANISM WITH PINS ¿WHICH HOLDS INTO THE BONE AND ALLOWS FOR A/P TRANSLATION¿ DISSOCIATED FROM THE BLOCK ITSELF. 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 22736505 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, A PIECE OF METAL LID OF A JOURNEY DCF AP FEM CUT BLK 5 SNAPPED OFF DURING REMOVAL. AT THIS TIME, IT IS UNKNOWN IF PIECES FELL INTO THE 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 22709113 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 5 WAS POSITIONED ON DISTAL FEMUR WITH IMPACTOR BLOCK, ON COMPLETION OF FINAL ANTERIOR CHAMFER CUT, THE CENTER SET SCREW POPPED OUT OF THE BLOCK INTO STERILE DRAPES AT FOOT. SET SCREW RETRIEVED AND BLOCK REMOVED BY SURGEON. 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 21933624 ↗
• MalfunctionApr 29, 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 5 DISASSOCIATED. THE PEGS WERE LEFT IN THE PATIENT WHEN THE CUT BLOCK WAS REMOVED WITH THE SLAP HAMMER. THE REMAINING PIECE HAD TO BE EXTRACTED USING A RONGEUR. THE SCREW MUST HAVE COME LOOSE ALLOWING THE TRANSLATION PEGS TO COME OFF THE BLOCK. 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 21931643 ↗
• MalfunctionApr 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 5 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 21851454 ↗
• MalfunctionApr 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE BACKPIECE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 5 FELL OFF AFTER CUTS WERE MADE. THE BLOCK WAS REMOVED AND IT WAS NOTICED THAT THE PIECE FELL OUT, BUT PIECE DID NOT FALL INTO PATIENT. 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 21752311 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE TRYING TO SLAP ONE (1) JOURNEY DCF AP FEM CUT BLK 5 OUT, IT WAS NOTICED THAT THE METAL WAS BROKEN OFF ON ONE SIDE OF THE SLAP HAMMER ATTACHMENT POINT. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551032 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY THE SCREW OF ONE (1) JOURNEY DCF AP FEM CUT BLK 5 FELL OUT OF THE BACK OF THE CUT BLOCK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228831 ↗
• MalfunctionDec 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A CORI ROBOTIC TKR PROCEDURE, THE SURGEON IMPACTED THE JOURNEY DCF AP FEM CUT BLK 5 ONTO THE FEMUR. WHILE REMOVING IT, USING THE SLAPHAMMER, THE BLOCK DISINTEGRATED INTO THE PIECES SEEN IN THE IMAGES. ALL PIECES WERE LOCATED AND REMOVED FROM THE SURGICAL FIELD UTILIZING FORCEPS. THE CUTS WERE ALREADY MADE; THEREFORE, 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 21047586 ↗
• MalfunctionDec 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA CASE, WHILE USING A SLAP HAMMER TO REMOVE BLOCK FROM FEMUR, BOTH WINGS DISENGAGED FROM THE JOURNEY DCF AP FEM CUT BLK 5. 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 20984808 ↗
• MalfunctionDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SPIKES OF THE JOURNEY DCF AP FEM CUT BLK 5 GOT DISCONNECTED FROM THE CUTTING BLOCK WHEN THE SLAP HAMMER WAS USED TO REMOVE THE BLOCK. SURGERY CONTINUED USING THE SAME DEVICE, WITHOUT DELAY. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859317 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CUTTING SLOT BROKE OFF OF THE JOURNEY DCF AP FEM CUT BLK 5. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, BUT IT IS UNKNOWN HOW. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606399 ↗
• MalfunctionOct 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE PART OF THE TAB OF A JOURNEY DCF AP FEM CUT BLK 5 THAT THE SLAP HAMMER ATTACHES TO BROKE OFF. THE BROKEN PIECE WAS RECOVERED. NOTHING FELL INSIDE THE WOUND AS THE BREAK WASN'T COMPLETE INSIDE THE WOUND. 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 20428970 ↗

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