JOURNEY 74012413Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 3 · Class 2
Quick summary
This Smith & Nephew Journey femoral cutting block is used during knee replacement surgery to guide bone cuts. The 51 reports mostly describe parts breaking or coming loose mid-operation — knobs, screws, pins and captures detaching, sometimes falling off the block or into the patient — with surgery delayed and then continued using the same or a backup block. There are 11 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 03596010556653), received between Sep 11, 2018 and Apr 18, 2026 — classified as 11 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (20 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.
Reports received per month
Most reported problems
Device problems
- Break20
- Detachment of Device or Device Component10
- Device Contamination with Chemical or Other Material6
- Device Reprocessing Problem6
- Fracture3
- Material Separation2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN ON ONE (1) JOURNEY DCF AP FEM CUT BLK 3 CAME OUT AND THE BLOCK FELL APART. 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 24919504 ↗MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TKA SURGERY, IN A JOURNEY DCF AP FEM CUT BLK 3, THE PUNCH LUGS WERE LOOSENING AND WILL NOT TIGHTEN UP. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 23656878 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY DCF AP FEM CUT BLK 3 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 21047711 ↗MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE KNOB OF A JOURNEY DCF AP FEM CUT BLK 3 CAME OFF THE DEVICE. THE PROCEDURE WAS RESUMED, AFTER A 10 MINUTE DELAY, WITH THE SAME DEVICE. ALL PIECES WERE REMOVED AND ACCOUNTED FOR BUT IS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652654 ↗MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING CUTTING IN A TKA SURGERY, THE SCREW THAT ALLOWS THE JOURNEY DCF AP FEM CUT BLK 3 TO MOVE ANTERIOR/POSTERIOR FELL 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 20559050 ↗MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TKA PROCEDURE, ONE (1) JOURNEY DCF AP FEM CUT BLK 3 KNOB WAS LOOSEN WHILE USING THE DEVICE. THE KNOB INCLUDING THE RELATED PARTS DROPPED OFF THE DEVICE. AFTER CONTINUING BONE CUT USING THE SAME DEVICE, THE SPIKED CROSS BAR AND CROSS BAR SCREW DROPPED OFF IT WHEN THE DEVICE WAS REMOVED. THE SURGERY WAS COMPLETED AFTER THE PARTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT BODY. A 20 MINUTES DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440457 ↗MalfunctionMay 20, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TOP TWO CAPTURES OF A JOURNEY DCF AP FEM CUT BLK 3 BROKE OFF WHEN BEING FIXATED TO THE FEMUR. ALL THE BROKEN PIECES WERE RETRIEVED AND THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16970540 ↗MalfunctionApr 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING THE CUTTING PHASE OF A TKA, THE KNOB TO MOVE A JOURNEY DCF AP FEM CUT BLK 3 A/P CAME LOOSE AND EVENTUALLY FELL OUT. 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 16735035 ↗MalfunctionOct 4, 2022Fracture; Fracture
IT WAS REPORTED THAT THE JOURNEY DCF AP FEM CUT BLK 3 IS FRACTURE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15535465 ↗MalfunctionJul 20, 2022Break; Break
IT WAS REPORTED THAT, ONE (1) JOURNEY DCF AP FEM CUT BLK 3 WAS BROKEN. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15067030 ↗MalfunctionJul 19, 2022Fracture; Fracture
IT WAS REPORTED THAT, A JOURNEY DCF AP FEM CUT BLK 3 FRACTURED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15058646 ↗MalfunctionJul 19, 2022Break; Break
IT WAS REPORTED THAT, ONE (1) JOURNEY DCF AP FEM CUT BLK 3 WAS BROKEN. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15054493 ↗MalfunctionMay 23, 2022Break; Break
IT WAS REPORTED THAT THE JOURNEY DCF AP FEM CUT BLK 3 WAS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14470642 ↗MalfunctionMay 21, 2022Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF CUTTING SLOT BROKE OFF THE JOURNEY DCF AP FEM CUT BLK 3. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14466755 ↗MalfunctionMay 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT, A JOURNEY DCF AP FEM CUT BLK 3 ASSEMBLY FELL APART. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359842 ↗MalfunctionMay 5, 2022Crack; Material Deformation; Crack; Material Deformation
IT WAS REPORTED THAT A JOURNEY DCF AP FEM CUT BLK 3 WAS FOUND BURRED AND CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14285787 ↗InjuryMar 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CENTER OF A JOURNEY DCF AP FEM CUT BLK 3 CAME OFF WHEN REMOVING THE BLOCK WITH A SLAP HAMMER. INCIDENT OCCURRED WITH INSTRUMENTS INSIDE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13720730 ↗MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, WHEN REMOVING A JOURNEY DCF AP FEM CUT BLK 3 AFTER A TKA PROCEDURE, THE BLOCK DISASSEMBLED. ALL PIECES WHERE RECOVERED. NO DELAYS REPORTED. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13578349 ↗MalfunctionFeb 17, 2022Mechanics Altered; Mechanics Altered
IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA, THE ROTATIONAL MECHANISM OF A JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 3 IS LOOSE/WILL NOT LOCK. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13553135 ↗MalfunctionFeb 16, 2022Break; Break
IT WAS REPORTED THAT THE JOURNEY DCF AP FEM CUT BLK 3 BROKE. FURTHER INFORMATION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13540308 ↗InjuryJan 10, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 3 FELL APART. SURGEON HAD TO RETRIEVE ALL THE LITTLE PARTS FROM PATIENT'S KNEE WITH TWEEZERS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13208460 ↗MalfunctionNov 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, THE SCREW CAME OUT OF BACK OF JOURNEY DCF AP FEM CUT BLK 3, 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 12875671 ↗MalfunctionNov 9, 2021Break; Break
IT WAS REPORTED THAT, THE SPRING BROKE INSIDE THE SCREW MECHANISM ON THE JOURNEY DCF AP FEM CUT BLK 3 TO MOVE IT UP AND DOWN. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780480 ↗InjuryMar 10, 2021Material Separation; Material Separation
IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE CENTER OF A JOURNEY DCF AP FEM CUT BLK 3 CAME OFF DURING REMOVAL, INSTRUMENTS WERE INSIDE THE PATIENT. THERE WAS NO DELAY REPORTED AND PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11449988 ↗MalfunctionMar 3, 2021Break; Break
IT WAS REPORTED THAT, THE BACK OF A JOURNEY DCF AP FEM CUT BLK 3 WAS FOUND BROKEN. NO CASE WERE REPORTED; THEREFORE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11403058 ↗
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, ClassifiedLEGION 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 · TerminatedSmith+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 · Terminatedsmith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
- Z-1902-2018 · Apr 9, 2018 · Terminatedsmith&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
Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.