JOURNEY 74012417Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 03596010556691), received between Oct 15, 2018 and Aug 18, 2026 — classified as 9 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304618 ↗
• MalfunctionAug 17, 2026Detachment of Device or Device Component

  It was reported that, during TKA surgery, cutting block knob of (one) 1 JOURNEY DCF AP FEM CUT BLK 7came off. 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 50268758 ↗
• MalfunctionJun 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A CORI TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 7 HAD IMPACTION/BACKSLAP SLOT BROKEN DURING REMOVAL FROM FEMUR AFTER FEMORAL CUTS. 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 25494332 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE BACK OF ONE (1) JOURNEY DCF AP FEM CUT BLK 7 BROKE INTO PIECES. 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 23821602 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PEG OF THE JOURNEY DCF AP FEM CUT BLK 7 BROKE. 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 23699780 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A METAL PIECE CAME OFF WHEN IMPACTING ONE (1) JOURNEY II SZ 7 CUTTING BLOCK. 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 23430839 ↗
• MalfunctionOct 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE CUTTING THROUGH THE SLOTS OF ONE (1) JOURNEY DCF AP FEM CUT BLK 7, THE CENTER CONSOLE FELL APART. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING AN EQUIVALENT S+N BACKUP DEVICE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210091 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 7 BROKE. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY, IF THERE WAS A DELAY OR IF ANY INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028253 ↗
• MalfunctionJul 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE ANTERIOR CUTTING SLOT OF A JOURNEY DCF AP FEM CUT BLK 7, FRACTURED. THE PRODUCT AND ALL ITS PIECES WERE RETRIEVED. NOTHING LEFT INSIDE 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 22465357 ↗
• MalfunctionMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, IT WAS NOTICED THAT ONE (1) JOURNEY DCF AP FEM CUT BLK 7 HAS A BROKEN EDGE FOR EXTRACTION. 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 22101649 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 7 BROKE IN HALF DURING IMPACTION. 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 21995760 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BACKSIDE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 7 BROKE OFF WHILE USING THE SLAP HAMMER TO REMOVE IT FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894991 ↗
• MalfunctionMar 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN USING THE UNIVERSAL EXTRACTION TOOL TO REMOVE THE JOURNEY DCF AP FEM CUT BLK 7 OF THE FEMUR, A SMALL PIECE OF METAL BROKE OFF THE CENTER OF THE CUTTING BLOCK. IT IS UNKNOWN IF ANY PIECE FELL INSIDE 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 21696531 ↗
• MalfunctionFeb 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW THAT HOLDS THE SPIKES TO THE BACK OF THE JOURNEY DCF AP FEM CUT BLK 7 WAS BROKEN. 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 21478506 ↗
• MalfunctionDec 5, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHILE CUTTING THROUGH THE JOURNEY DCF AP FEM CUT BLK 7, A PIECE OF METAL BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858460 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, THE SCREW OF A (1) JOURNEY DCF AP FEM CUT BLK 7 WAS COMING OUT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO DELAY NOR INJURY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797054 ↗
• MalfunctionOct 17, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SCREW ON BACK OF A JOURNEY DCF AP FEM CUT BLK 7 BROKE. IN ADDITION, THE BLOCK PEGS ON THE BACK ARE DISASSEMBLED. ALL PIECES WERE RECOVERED. THE FOLLOWING STATEMENT WAS PROVIDED "NOTHING IN PATIENT", BUT IT IS UNCLEAR IF THIS MEANS THAT NO PIECES FELL INTO PATIENT, OR IF NO PIECES WERE LEFT IN THE 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 20477877 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 7 BROKE DURING USE. THE CUTS HAD ALREADY BEEN MADE, SO THE SURGEON WAS ABLE TO COMPLETE THE OPERATION WITHOUT A PROBLEM. THE SURGERY WAS COMPLETED, AFTER A SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE. NO OTHER INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252262 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A PART OF A JOURNEY DCF AP FEM CUT BLK 7 BROKE OFF DURING IMPACTION ONTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030279 ↗
• MalfunctionFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SMALL SCREW IN THE BACK OF A JOURNEY DCF AP FEM CUT BLK 7 CAME OFF THE BACK. THE SCREW WAS PUT IN A TRAY BY THE SURGICAL TECH AFTER THE CASE, BUT NOW CANNOT BE LOCATED. 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 18767217 ↗
• MalfunctionJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN REMOVING ONE (1) JOURNEY DCF AP FEM CUT BLK 7, A SMALL BALL BEARING FELL OUT OF THE SLIDING MECHANISM OF THE BLOCK. THE BEARING WAS RETRIEVED. THE BLOCK APPEARS NORMAL TO THE NAKED EYE, BUT THE PEGS ON THE BACK OF THE BLOCK MOVE SLIGHTLY EVEN WHEN SCREW WAS COMPLETELY LOCKED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18464764 ↗
• MalfunctionDec 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE CENTRAL TABS OF TWO (2) JOURNEY DCF AP FEM CUT BLK 7 BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383590 ↗
• MalfunctionDec 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 7 BROKE AFTER CUTS WERE MADE AND IT WAS REMOVED FROM PATIENT. NO PIECES FELL INSIDE PATIENT. 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 18383053 ↗
• MalfunctionDec 20, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE SPIKES ON THE BACK OF ONE (1) JOURNEY DCF AP FEM CUT BLK 7 BECAME DISENGAGED, IT LOOKS LIKE THE SCREW ATTACHMENT BROKE. THIS OCCURRED AS THE BLOCK WAS BEING REMOVED OF THE PATIENTS KNEE. ALL PIECES WERE RECOVERED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370333 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA, WHEN TAKING OFF A JOURNEY DCF AP FEM CUT BLK 7 WITH THE SLAP HAMMER IT ENGAGED WITH THE TWO SMALL METAL PIECES AROUND THE MIDDLE KNOB AND THEY WERE PULLED OFF, THEREFORE, TWO LITTLE METAL PLATES AROUND THE KNOB OF THE CUTTING BLOCK JUST BROKE OFF. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, BUT IT REMAINS UNCLEAR HOW, HOWEVER NO DELAY HAS BEEN REPORTED. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18218448 ↗

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