NAVIO ROB00006Recalls & reported problems
Smith & Nephew, Inc. · NAVIO Total Knee Arthroplasty FEMUR DISTAL CUT GUIDE MEDIUM · Class 2
All models of Navio (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556685082), received between Feb 15, 2021 and Feb 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2021Break; Break
IT WAS REPORTED THAT DURING THE FEMUR CUTTING STAGE OF A NAVIO TKA PROCEDURE, IT WAS FOUND THAT THE FEMUR DISTAL CUT GUIDE WAS DAMAGED, ITS SCREW WAS BROKEN. IT WAS BROKEN WHEN PLACING ON THE PATIENT'S BONE, HOWEVER, ALL THE BROKEN PIECES FELL ON THE OPERATING TABLE. THEY CONTINUED WITH THE ANOTHER FEMUR TKA CUT GUIDE FROM ANOTHER TRAY WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11327844 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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