EVOS 72463909Recalls & reported problems
Smith & Nephew, Inc. · EVOS 2.7MM/3.5MM MEDIAL DISTAL TIBIA PLATE 9 HOLE LEFT 130MM · Class 2 · Implant
All models of EVOS (190)
Data updated Oct 16, 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 00885556640838), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING THE PROCEDURE, AT THE TIME OF OPENING THE EVOS 2.7/3.5 MM MEDIAL DISTAL TIBIA. ENVELOPE, THE STERILE PACKAGE WAS DAMAGED. IT SEEMS THAT IT WAS NOT BLISTERED. THE SURGEON DECIDED TO USE THE ITEM, THEREFORE, ONLY THE PRODUCT PACKAGE WILL BE SENT FOR FURTHER INVESTIGATION. NO INJURIES OR SURGICAL DELAYS WERE REPORTED. BACKUP DEVICE INFORMATION WAS NOT INITIALLY PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9833781 ↗
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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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