EVOS 72585214Recalls & reported problems
Smith & Nephew, Inc. · EVOS 3.5MM/4.5MM PERIPROSTHETIC DISTAL FEMUR PLATE R 14H 297MM · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556771105), received between Jun 28, 2024 and Jun 28, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT VISITED ED DUE TO GLF, RIGHT SUPRACONDYLAR DISTAL FEMUR FRACTURE AROUND REV TKA STEM, AND REQUIRED AN ORIF FIXATION WITH EVOS PLATE AND SCREWS. THE PATIENT UNDERWENT REVISION SURGERY 201 DAYS AFTER PRIMARY PROCEDURE DUE TO PAIN OVER THE IMPLANTS. DURING THE REVISION, THE PLATE AND SCREWS WERE EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Implant Pain
MAUDE report 19638485 ↗
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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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