Harmony 74016205Recalls & reported problems
Smith & Nephew, Inc. · DISTAL FEMUR CUTTING BLOCK · Class 1
All models of Harmony (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556735213), received between Jul 29, 2021 and Jan 27, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 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
- Material Fragmentation2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A TKA SURGERY, UPON PINNING THE GUIDE TO THE BONE THE ¿0¿ HOLE OF ONE (1) DISTAL FEMUR CUTTING BLOCK WASN¿T ALLOWING A PIN TO GO THROUGH CAUSING MINIMAL METAL SHARDS. THE PROCEDURE WAS COMPLETED, AFTER A NON SIGNIFICANT 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 24188693 ↗MalfunctionApr 17, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS FOUND THAT IN ONE (1) DISTAL FEMUR CUTTING BLOCK METAL PARTICLES ENTERED THE JOINT DURING SAWING. AFTER THE PROCEDURE, IN THE POST-OPERATIVE INSPECTION, THE DAMAGED WAS NOTICED, INCLUDING SEVERE WEAR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW WAS THE SURGERY COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861282 ↗InjuryJul 29, 2021Defective Device; Defective Device
IT WAS REPORTED THAT DURING A TKA, THE DISTAL FEMUR CUTTING BLOCK SECOND HOLE WAS FOUND TO HAVE A RELIEF CUT THAT GOES THRU THE PIN HOLE, AND CUTS THE PIN. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THIS CAUSED ANY DELAY. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12250743 ↗
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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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