NAVIO ROB00061Recalls & reported problems
Smith & Nephew, Inc. · NAVIO TKA DISTAL FEMUR PUNCH - 45MM · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556709405), received between Feb 25, 2021 and Feb 25, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING CORI TKA PROCEDURE, THE SURGEON REALIZED THERE WAS SOME PLAY WITH THE PUNCH TOOL. HE WAS ANTERIOR 1.5 MM AFTER CAREFULLY SEATING AND MALLETING THE PUNCH TOOL IN THE FEMORAL LUGS, WHICH WERE PREPARED WITH A 5MM BUR. THE CASE WAS SET FOR LEGION PS. THE BONE WAS HARD. HE MOVED THE DISTAL CUTTING BLOCK POSTERIOR TO CORRECT THIS, AS CONFIRMED WITH THE PLANE VISUALIZATION TOOL. DELAY REPORTED LESS THAN 30 MINUTES. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11381243 ↗
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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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