JOURNEY 74011821Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY FEMORAL IMPLANT IMPACTOR BUMPER RIGHT · Class 1
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Journey femoral impactor bumper is a surgical tool used to tap the thigh bone implant into place during knee replacement. Of its 279 reports, 249 are malfunction reports, mostly describing pegs and parts breaking or cracking during surgery, and 30 are injury reports. Many reports say the surgery continued without delay. There were 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
- 279
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 03596010556455), received between Sep 24, 2018 and Jun 12, 2026 — classified as 30 injuries, 249 malfunctions.
The most frequently reported specific device problem is “Break” (197 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.
Reports received per month
Most reported problems
Device problems
- Break197
- Fracture67
- Crack11
- Material Fragmentation3
- Naturally Worn3
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions214
- No Consequences Or Impact To Patient28
- No Known Impact Or Consequence To Patient20
- No Patient Involvement19
- No Information4
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 279 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BUTTON OF ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE IN THE IMPACTOR. 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 25494394 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE RIGHT PEGS OF ONE (1) JOURNEY FEM IMPACT BUMPER RT FRACTURED. NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25131252 ↗MalfunctionFeb 23, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CONNECTING PEG OF A JOURNEY FEM IMPACT BUMPER RT BROKE OFF WHEN IMPACTING. THERE WAS NO INJURY AND NO PARTS WERE LEFT BEHIND IN 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 24413129 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT, DURING TKA SURGERY, THE JOURNEY FEM IMPACT BUMPER RT 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 24101293 ↗MalfunctionDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FEM IMPACT BUMPER RT BROKE AFTER IMPACTION OF FEMUR IMPLANT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; AND, IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920467 ↗MalfunctionDec 10, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A KNEE SURGERY, THE PEG OF THE JOURNEY FEM IMPACT BUMPER RT BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774347 ↗MalfunctionOct 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE PEG OF ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE OFF IN TOP THE HANDLE. NOTHING FELL INTO PATIENT. ALL PIECES RETRIEVED. 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 23430856 ↗MalfunctionOct 23, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, ONE OF THE ATTACHMENT PEGS ON THE JOURNEY FEM IMPACT BUMPER RT BROKE DURING IMPACTION. THE EVENT HAPPENED OUTSIDE OF THE PATIENT'S ANATOMY, SO NO PIECES WERE LEFT BEHIND. PATIENT LEFT SURGERY IN GOOD HEALTH. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364720 ↗MalfunctionOct 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A PEG OF ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE OFF 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 23310957 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER RT 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 22329274 ↗MalfunctionApr 26, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE PLASTIC PIECE OF ONE (1) JOURNEY FEM IMPACT BUMPER RT FELL OFF AFTER THE FINAL IMPLANT WAS IMPACTED. THE PROCEDURE HAD BEEN 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 21915676 ↗MalfunctionApr 24, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE WHILE IMPACTING FEMUR, BROKEN PIECE WAS RETRIEVED. 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 21898548 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FEM IMPACT BUMPER RT 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 21628162 ↗MalfunctionMar 17, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE 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 21628004 ↗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 21627997 ↗MalfunctionMar 5, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE PLASTIC NUBS ON A JOURNEY FEM IMPACT BUMPER RT BROKE OFF. AT THIS TIME, IT IS UNKNOWN IF ANY PIECES FELL INTO 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 21531988 ↗MalfunctionJan 28, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY FEM IMPACT BUMPER RT BROKE DURING IMPACTION AND BROKEN PIECES WERE DISCARDED BY CENTRAL STERILE. 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 21253387 ↗MalfunctionJan 7, 2025Break; Fracture; Separation Failure; Break; Fracture; Separation Failure
IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY FEM IMPACT BUMPER RT BROKE WHILE IMPACTING FEMUR, ONE OF THE PEGS GOT STUCK IN THE IMPACTOR. ONE OF THE BUMPER PEGS BROKE OFF SO IT WAS NOT FUNCTIONAL. 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 21091845 ↗MalfunctionDec 6, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JOURNEY FEM IMPACT BUMPER RT HAS BROKEN WHILE IN USE, THUS IN A PATIENT. SALES REP ASSUME BROKEN PARTS WERE RETRIEVED WITH FORCEPS. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20872871 ↗MalfunctionOct 29, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE AFTER THE SURGEON HIT THE IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556326 ↗MalfunctionOct 12, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE WHEN IT WAS SEPARATED FROM THE IMPACTOR. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20435527 ↗MalfunctionAug 28, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPACT BUMPER RT FRACTURED. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE RESUMED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THIS ISSUE CAUSED A DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20092468 ↗MalfunctionAug 21, 2024Break; Break
IT WAS REPORTED THAT, DURING IMPLANTATION IN A TKA SURGERY, TWO (2) JOURNEY FEM IMPACT BUMPER RT 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 20013773 ↗MalfunctionAug 6, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN THE BLUE RIGHT ATTACHMENT WAS REMOVED AFTER USE OF A JRN II BCS LCK FEM IMPLANT IMPACT, PEG BROKE. THE PEG WAS STUCK INSIDE THE JRN II BCS LCK FEM IMPLANT IMPACT AND THE ATTACHMENT WAS BROKEN AS WELL. THE PIECES DID NOT FALL IN THE PATIENT. 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 19919234 ↗MalfunctionJul 31, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE PEG ON THE BOTTOM OF ONE (1) JOURNEY FEM IMPACT BUMPER RT BROKE OFF. NOTHING FELL INTO THE PATIENT. 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 19874707 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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