Harmony 74016250Recalls & reported problems
Smith & Nephew, Inc. · MODULAR LEGION FEMORAL IMPACTOR · Class 1
Quick summary
This Smith & Nephew modular femoral impactor is a surgical instrument used to hammer knee implants into place during total knee replacement surgery. The 49 reports describe the plastic breaking or snapping during surgery, sometimes leaving a fragment lodged in the handle, while surgeons continued the operation with a backup instrument. No deaths, injuries, or recalls are recorded.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00885556746691), received between Oct 5, 2022 and Jul 14, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Fracture” (35 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
- Fracture35
- Break15
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818258 ↗MalfunctionMar 19, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKEN OFF. WAS PUT ON THE IMPACTION HANDLE AND THE CONNECTION PIECE "SNAPPED OFF" INSIDE THE HANDLE. THE PROCEDURE WAS PERFORMED, 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 24638517 ↗MalfunctionMar 7, 2026Break; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE MODULAR LEGION FEMORAL IMPACTOR BROKE. 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 24539970 ↗MalfunctionJan 12, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC OF TWO (2) MODULAR LEGION FEMORAL IMPACTOR BROKE. 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 24036628 ↗MalfunctionDec 22, 2025Break; Break
IT WAS REPORTED THAT DURING A TKA A MODULAR LEGION FEMORAL IMPACTOR BROKE WHILE IMPACTING THE FEMUR IMPLANT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864921 ↗MalfunctionNov 30, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE MODULAR LEGION FEMORAL IMPACTOR BROKE. PHYSICALLY BROKEN, THE PART THAT ATTACHES TO THE MODULAR HANDLE WAS BROKEN UPON IMPACTION. 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 23677319 ↗MalfunctionNov 4, 2025Break; Break
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE WHILE BEING USED. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461731 ↗MalfunctionAug 12, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON HIT THE HANDLE CONNECTED TO THE SECONDARY MODULAR LEGION FEMORAL IMPACTOR, AND THE STEM OF IT, BROKE. THE STEM BROKE AND STAYED INSIDE THE HANDLE, THE BLOCK FELL ONTO THE OPERATING TABLE. NO PIECES WENT INSIDE THE PATIENT BECAUSE IT WAS A CLEAN BREAK SO NOTHING HAD TO BE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, AND WITHOUT THE IMPACTOR. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783484 ↗MalfunctionMar 21, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE POST ON ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE DURING IMPACTION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21664054 ↗MalfunctionMar 5, 2025Break; Break
IT WAS REPORTED THAT, DURING A TKA, WHILE IMPACTING THE FEMUR, A (1) MODULAR LEGION FEMORAL IMPACTOR BROKE AT CONNECTION POINT. 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 21532731 ↗MalfunctionMar 5, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE IMPACTING THE FEMUR THE MODULAR LEGION FEMORAL IMPACTOR WAS CRACKED AND BROKEN. 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 21532493 ↗MalfunctionJan 15, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE AFTER BEING STRUCK. 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 21164742 ↗MalfunctionDec 6, 2024Break; Break
IT WAS REPORTED THAT, DURING A TKA WHEN IMPACTING THE FINAL FEMORAL IMPLANT WITH THE IMPACTOR, A (1) MODULAR LEGION FEMORAL IMPACTOR BROKE AT THE BASE OF THE MODULAR 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'S STATUS IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20861039 ↗MalfunctionNov 7, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A MODULAR LEGION FEMORAL IMPACTOR BROKE AT TIP WHILE IMPACTING. ALL PIECES WERE RECOVERED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER NO SUBSTANTIAL 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 20630484 ↗MalfunctionOct 25, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A MODULAR LEGION FEMORAL IMPACTOR BROKE UPON IMPACTION. 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 20533788 ↗MalfunctionOct 17, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN IMPACTING THE FINAL IMPLANT ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE. IT IS UNKNOWN IF THE EVENT CAUSED ANY DELAY, OR HOW WAS THE PROCEDURE FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477182 ↗MalfunctionOct 14, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING IMPACTION IN A TKA SURGERY, ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440497 ↗MalfunctionSep 9, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE DURING IMPACTION. ALL PIECES WERE RECOVERED FROM INSIDE THE PATIENT. 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 20170056 ↗MalfunctionAug 26, 2024Break; Break
IT WAS REPORTED THAT DURING A TKA, IT WAS REPORTED THAT A MODULAR LEGION FEMORAL IMPACTOR BROKE. 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 20065695 ↗MalfunctionAug 15, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA, A MODULAR LEGION FEMORAL IMPACTOR BROKE WHEN PUTTING ON IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT HEALTH STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991248 ↗MalfunctionAug 12, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) MODULAR LEGION FEMORAL IMPACTOR FRACTURED AT THE STEM AREA AFTER IMPACTING THE FEMUR. NO PIECES FELL INTO 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 19968550 ↗MalfunctionAug 12, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, UPON IMPACTION OF FEMUR IMPLANT THE MODULAR LEGION FEMORAL IMPACTOR BROKE. 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 19968487 ↗MalfunctionAug 5, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) MODULAR LEGION FEMORAL IMPACTOR FRACTURED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH ANOTHER INSTRUMENT SET. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19906238 ↗MalfunctionJul 31, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, UPON IMPACTING THE FEMUR, IT WAS NOTICED THAT MODULAR LEGION FEMORAL IMPACTOR SNAPPED AT THE POINT BETWEEN THE PLASTIC AND THE UNIVERSAL HANDLE. IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT. 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 19875802 ↗MalfunctionJul 22, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) MODULAR LEGION FEMORAL IMPACTOR BROKE. ALL THE PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19793735 ↗
Other IMPACTOR devices
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- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.