Harmony 74016252Recalls & reported problems
Smith & Nephew, Inc. · MODULAR JOURNEY FEMORAL IMPACTOR · Class 1
Quick summary
This Smith & Nephew modular femoral impactor is a plastic surgical instrument used to shape the femur during knee replacement surgery. The reports mostly describe the impactor cracking or snapping during surgery, often at the point where it joins the handle, and once trouble attaching it to the handle; in the cases described, surgeons finished the operation with a backup instrument and no fragments were left inside patients. There are 38 adverse event reports, 3 injuries and no deaths. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00885556746714), received between Apr 1, 2022 and Feb 10, 2026 — classified as 3 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (27 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture27
- Break11
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR FRACTURED AT THE CONNECT AND WAS UNABLE TO BE USED FURTHER. 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 24310525 ↗MalfunctionNov 13, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE TIP OF ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR BROKE WHILE SECONDARILY IMPACTING THE FEMUR. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SIMILAR SMITH & NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542272 ↗MalfunctionMar 27, 2025Break; Difficult to Insert; Break; Difficult to Insert
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR WAS BROKEN; ALSO, IT WAS DIFFICULT TO ATTACH TO MODULAR HANDLE. 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 21708521 ↗MalfunctionNov 7, 2024Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR BROKE WHILE IMPACTING THE FEMUR. IT IS UNKNOWN IF THERE WAS A S+N BACK UP DEVICE AND WHETHER THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630260 ↗MalfunctionMar 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR FRACTURED AT THE JUNCTION WHERE IT INSERTS TO THE MODULAR HANDLE. THE PROCEDURE HAD BEEN COMPLETED WITHOUT ANY DELAY, USING THE SAME DEVICE. NO PIECES OF THE BROKEN IMPACTOR FELL INSIDE THE PATIENT, AND NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921989 ↗MalfunctionMar 13, 2024Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE ORANGE POLY OF A MODULAR JOURNEY FEMORAL IMPACTOR BROKE AT 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 18893947 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE PLASTIC INSERT OF A MODULAR JOURNEY FEMORAL IMPACTOR BROKE WHILST FEMUR WAS BEING IMPACTED. 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 18827393 ↗MalfunctionJan 20, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR BROKE FROM THE HANDLE ON IMPACTION, THE HEAD THAT CONTACTS THE BODY WAS NOT DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 18548855 ↗MalfunctionDec 22, 2023Fracture; Fracture
IT WAS REPORTED THAT, A MODULAR JOURNEY FEMORAL IMPACTOR FRACTURED AFTER IMPACTING FEMUR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND NO PIECES FELL INTO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383510 ↗MalfunctionDec 12, 2023Break; Break
IT WAS REPORTED THAT, DURING A TKA, THE HEAD OF ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR SNAPPED OFF THE POST THAT INSERTS INTO THE HANDLE. NO PIECES WERE SEEN IN THE JOINT BUT IT WAS PROPHYLACTICALLY IRRIGATED TO ENSURE NO UNSEEN PIECES WERE LEFT IN THE JOINT. 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 18311778 ↗MalfunctionNov 8, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING THE IMPACTION OF THE FEMUR IN TKA SURGERY, THE HEAD OF A MODULAR JOURNEY FEMORAL IMPACTOR FELL TO THE FLOOR. THE HEAD BROKE OFF THE LOCKING POST THAT WAS IN THE MODULAR HANDLE. NO PIECES WERE SEEN OR LEFT IN THE PATIENT. THE JOINT WAS IRRIGATED TO ENSURE NO PLASTIC WAS LEFT. 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 18096924 ↗MalfunctionSep 13, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, UPON IMPACTION ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741905 ↗MalfunctionJul 5, 2023Break; Break
IT WAS REPORTED THAT DURING A TKA, THE MODULAR JOURNEY FEMORAL IMPACTOR WAS NOTICED TO HAVE BROKEN IN MODULAR IMPACTOR HANDLE AFTER FINISHING IMPACTING THE FINAL IMPLANT. 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 17257426 ↗MalfunctionMay 11, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN IMPACTING THE FEMUR, THE NECK OF THE PLASTIC PIECE OF THE MODULAR JOURNEY FEMORAL IMPACTOR DEVICE SNAPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. NOTHING LOST IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16911771 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED THAT, DURING TKA SURGERY,, ONE (1) MODULAR JOURNEY FEMORAL IMPACTOR BROKE WHILE IMPACTING FEMUR. 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 16854408 ↗MalfunctionApr 13, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE MODULAR JOURNEY FEMORAL IMPACTOR DEVICE BROKE WHEN IMPACTING THE REAL FEMUR. NO PIECES FELL INTO 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 16732287 ↗MalfunctionMar 27, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING THE FEMUR TRIAL, A MODULAR JOURNEY FEMORAL IMPACTOR BROKE. SURGERY WAS RESUMED, WITHOUT ANY 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 16624642 ↗MalfunctionMar 26, 2023Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE POST OF A MODULAR JOURNEY FEMORAL IMPACTOR, THAT INSERTS INTO THE IMPACTOR HANDLE BROKE OFF. 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 16616864 ↗MalfunctionMar 23, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY, A MODULAR JOURNEY FEMORAL IMPACTOR SNAPPED ON THE NECK WHEN IMPACTING FEMUR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16607458 ↗MalfunctionFeb 4, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THAT TWO (2) MODULAR JOURNEY FEMORAL IMPACTOR BROKE WHILE IMPACTING FEMUR. 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 16301722 ↗MalfunctionFeb 1, 2023Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIPS OF TWO (2) MODULAR JOURNEY FEMORAL IMPACTORS BROKE OFF DURING IMPACTION. SURGERY WAS FINISHED, WITHOUT ANY DELAY, USING THE SAME DEVICES. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16278226 ↗MalfunctionJan 11, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A MODULAR JOURNEY FEMORAL IMPACTOR BROKE OFF DURING IMPACTION. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135369 ↗MalfunctionJan 10, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING USE, THE ORANGE PLASTIC BUMPER MODULAR JOURNEY FEMORAL IMPACTOR FRACTURED ON THE SECOND HAMMER BLOW DURING IMPLANTATION AND A OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR HAD A CLEAN CRACK ON THE BEND OF THE HANDLE. ADDITIONALLY, NO PIECES FELL INSIDE THE WOUND. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. THE CUSTOMER INDICATED THAT THE INSTRUMENTS WERE ALMOST NEW AND WERE BEING USED FOR THE SECOND TIME WHEN THE FAILURES WERE NOTICED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135361 ↗MalfunctionDec 30, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE MODULAR JOURNEY FEMORAL IMPACTOR TIP WAS BROKEN AT THE BASE. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY USING AN S+N BACK-UP DEVICE. NO PATIENT HARM OCCURRED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16077951 ↗MalfunctionNov 12, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CONNECTION PIECE (TIP) OF A MODULAR JOURNEY FEMORAL IMPACTOR BROKE OFF INSIDE HANDLE WHEN TRYING TO DISASSEMBLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15785908 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.