JOURNEY 74012414Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 03596010556660), received between Mar 6, 2019 and Aug 14, 2026 — classified as 15 injuries, 114 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. 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246130 ↗
• MalfunctionJun 29, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 4 WAS CHIPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE THE PATIENT. 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 25651456 ↗
• MalfunctionApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 4 CAME APART. 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 25046851 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE CUTTING THROUGH ONE (1) JOURNEY DCF AP FEM CUT BLK 4 IT FELL APART. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389013 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT WAS NOTICED THAT THE SCREW CAME OUT OF THE CENTER OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 DURING USE. 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 22801400 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY DCF AP FEM CUT BLK 4 HAD A PIECE OF METAL BREAK LOOSE FROM THE CUTTING SLOT. THE METAL PIECE WAS COMPLETELY RETRIEVED FROM THE PATIENT BY THE SURGEON. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644204 ↗
• MalfunctionJul 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SMALL PIECE THAT ATTACHES TO THE SLAP HAMMER OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 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 22551558 ↗
• MalfunctionJun 23, 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 22307729 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BACK PIECE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 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 22185589 ↗
• MalfunctionMay 20, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING TKA, ONE (1) JOURNEY DCF AP FEM CUT BLK 4 WAS BROKEN. 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 22057084 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CENTER SCREW OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 DISSOCIATED WHILE BEING CUT THROUGH AND IT CAME OFF IN PIECES UPON EXTRACTION. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO DELAY AND NO INJURY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027789 ↗
• MalfunctionApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW, SPRING, POST AND DUAL PIN POST OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 CAME APART IN SITU WHEN PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT. ALL PIECES WERE RECOVERED AND ACCOUNTED FOR USING A KOCHER. NO OPERATIVE REPORTS, SURGICAL NOTES, OR X-RAYS AVAILABLE. 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 21749248 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, ONE [1] JOURNEY DCF AP FEM CUT BLK 4 BROKE OFF WHILE IMPACTING THE CUTTING BLOCK ONTO THE BONE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 5-10 MIN 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 21126615 ↗
• MalfunctionDec 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE CENTER PIECE OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 BROKE. 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 20912983 ↗
• MalfunctionDec 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY DCF AP FEM CUT BLK 4 BROKE WHEN WAS HIT. NOTHING REMAINED IN PATIENT'S BODY. THE BROKEN PART WAS RECOVERED WITH TWEEZERS. 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 20815705 ↗
• MalfunctionAug 29, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE KNOB OF A JOURNEY DCF AP FEM CUT BLK 4 BROKE. NOTHING WAS LOST, AND NOTHING WAS FOUND IN PATIENT. 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 20096402 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, WHILE TRYING TO ADJUST THE JOURNEY DCF AP FEM CUT BLK 4, THE CENTER SCREW FELL OUT. IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352907 ↗
• MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING ONE (1) JOURNEY DCF AP FEM CUT BLK 4, THE BACK SPIKES DISENGAGED FROM THE BLOCK, AND THE SCREW THAT HOLDS IT TOGETHER FELL OUT. 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 19092949 ↗
• MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BACKSIDE SCREW OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 WENT MISSING. 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 19092857 ↗
• MalfunctionMar 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CHAMFER OF ONE (1) JOURNEY DCF AP FEM CUT BLK 4 BROKE OFF. 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 18974712 ↗
• MalfunctionMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE JOURNEY DCF AP FEM CUT BLK 4 WORKED FOR THE CUTS, AND BROKE WHILE TRYING TO REMOVE FROM FEMUR. ALL PIECES WERE PULLED OUT WITH A PLIERS AND ACCOUNTED FOR. 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 18831210 ↗
• MalfunctionMar 4, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY DCF AP FEM CUT BLK 4 BROKE WHILE BEING IMPACTED. 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 18826903 ↗
• MalfunctionFeb 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE METAL PART OF A JOURNEY DCF AP FEM CUT BLK 4 WAS SNAPPED OFF DURING IMPACTION. IT IS UNKNOWN HOW SURGERY WAS FINISHED AND IN THERE WAS A DELAY. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641964 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE JOURNEY DCF AP FEM CUT BLK 4 BACK CUT SLOT ON THE ANTERIOR CHAMBER CUT BROKE OFF. ALL DEBRIS WAS REMOVED USING PICK UPS AND SUCTION. 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 18472052 ↗
• MalfunctionJan 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT ONE (1) JOURNEY DCF AP FEM CUT BLK 4 BROKE IN CENTER WHERE SLAP HAMMER GOES TO REMOVE. 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 18465667 ↗

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