EVOS 72574211Recalls & reported problems
Smith & Nephew, Inc. · EVOS 4.5MM DISTAL FEMUR PLATE R 11H 233MM · 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 00885556753149), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 injury.
4 other recalls cover devices cleared under the same FDA submission (K201918, K213126); they may or may not involve this specific model.
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
- Nonunion/Delayed-union Bone Fracture1
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 A FALL DOWN 4 STAIRS, THAT RESULTED IN RIGHT SUPRACONDYLAR FEMUR FRACTURE WITH INTERCONDYLAR EXTENSION. THIS PATIENT UNDERWENT AN ORIF FIXATION WITH EVOS PLATE AND SCREWS. THE PATIENT UNDERWENT REVISION SURGERY 191 DAYS AFTER PRIMARY PROCEDURE DUE TO PAIN AND NON-UNION. DURING THE REVISION, THE PLATE AND SCREWS WERE EXPLANTED AND A NONUNION REPAIR WITH PLACEMENT OF INTRAMEDULLARY NAIL & BONE GRAFT WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture
MAUDE report 19638931 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201918, K213126. One submission often covers many models, so check the product and lot details in each record.
- Z-0365-2022 · Nov 1, 2021 · Terminatedsmith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
- Z-0363-2022 · Nov 1, 2021 · Terminatedsmith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
- Z-0364-2022 · Nov 1, 2021 · Terminatedsmith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
- Z-0366-2022 · Nov 1, 2021 · Terminatedsmith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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