JOURNEY 74012821Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 03596010556899), received between Jul 25, 2018 and Sep 19, 2026 — classified as 39 injuries, 256 malfunctions.

The most frequently reported specific device problem is “Break” (169 reports).

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 295 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50832703 ↗
• MalfunctionSep 15, 2026Fracture

  It was reported that, during a TKA surgery, one (1) JOURNEY FEM IMPACT BUMPER LT broke during impaction. 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 50766182 ↗
• MalfunctionSep 9, 2026Break

  It was reported that, during a TKA surgery, one (1) JOURNEY FEM IMPACT BUMPER LT broke upon impaction. The procedure was resumed, without any delay, using a equivalent S+N back-up product. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693642 ↗
• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE UPON IMPACTION OF THE FEMORAL COMPONENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25343052 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING THE FEMORAL COMPONENT, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE IN HALF. 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 25342389 ↗
• MalfunctionMay 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT FRACTURED. NO PIECES FELL INSIDE THE PATIENT'S 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 25273372 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE. 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 24800406 ↗
• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FEM IMPACT BUMPER LT CHIPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE 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 24029891 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TOTAL KNEE SURGERY, WHILE IMPACTING THE FEMUR, THE LEFT BUMPER PEG OF A JOURNEY FEM IMPACT BUMPER LT BROKE. NOTHING FELL INTO PATIENT AS PEG STAYED IN THE IMPACTOR. PIECE WAS RETRIEVED BY HAND. 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 23692800 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT WAS BROKEN. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617143 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT FRACTURED WHILE IMPACTING THE FEMUR. 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 22493193 ↗
• MalfunctionJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT WAS STRUCK WITH MALLET IMPACTING THE IMPLANT BUT WHEN THEY PULLED IT FROM THE JOINT THE BUMPER BROKE OFF. ALL PIECES RETRIEVED BY HAND. THE PIECE BROKEN OFF WAS STILL IN THE IMPACTOR. 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 22155350 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT FRACTURED WHILE BEING USED TO IMPACT THE FEMORAL COMPONENT. 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 21630713 ↗
• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PEG OF ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE DURING IMPACTION OF IMPLANT ON PATIENT'S FEMUR. ALSO, A PEG OF ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE OFF DURING IMPACTION WHEN INTRODUCING THE FEMORAL IMPLANT. 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 21627972 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY FEM IMPACT BUMPER LT SNAPPED IN HALF DURING IMPACTION. NOTING FELL INTO PATIENT. PIECE WAS RETRIEVED BY HAND SINCE IT WAS STILL ATTACHED TO IMPACTOR HANDLE. 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 21317013 ↗
• MalfunctionJan 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT WAS BROKEN WHILE IMPACTING THE FEMORAL COMPONENT. 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 21102017 ↗
• MalfunctionJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE 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 21055553 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JOURNEY FEM IMPACT BUMPER LT FRACTURED AND BROKE WHILE IMPACTING THE FEMORAL COMPONENT ONTO THE PATIENT. NO PIECES FELL IN THE PATIENT AND ALL ITEMS WERE RETRIEVED. ALSO, A JOURNEY LOCK FEM IMPL IMPACT CANNOT BE USED, AS THE LUGS ARE BLOCKED BY THE BROKEN BUMPER. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873025 ↗
• MalfunctionNov 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE WHILE BEING HIT WITH A MALLET. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO DELAY NOR FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630473 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JOURNEY FEM IMPACT BUMPER LT SNAPPED AND SHATTER WHEN CEMENTING. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146463 ↗
• MalfunctionSep 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT FRACTURED WHILE IN USE IMPLANTING A J2 BCS FEMORAL COMPONENT. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. 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 20131352 ↗
• MalfunctionAug 12, 2024Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY FEM IMPACT BUMPER LT BROKE DURING IMPACTION INTERNALLY TO PATIENT. ALL PIECES RECOVERED, NONE FELL INTO PATIENT. 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 19969010 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING IMPLANT INSERTION IN A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968196 ↗
• MalfunctionJul 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHILE IMPACTING IN A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER LT BROKE. ALL BROKEN PIECES WERE RETRIEVED AND RETURNED. THEY WERE RETRIEVED BY HAND AND WASHED OUT WITH FLUID AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19857018 ↗
• MalfunctionJul 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, DURING IMPACTION THE JOURNEY FEM IMPACT BUMPER LT NUB BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702319 ↗