EVOS 72574217Recalls & reported problems
Smith & Nephew, Inc. · EVOS 4.5MM DISTAL FEMUR PLATE R 17H 342MM · 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 00885556753170), received between Oct 20, 2023 and Oct 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).
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
- Migration or Expulsion of Device1
Patient problems
- 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.
InjuryOct 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY THE LOCKING SCREWS APPEARED TO STARTED BACKING OUT OF THE LOCKING HOLE ON THE EVOS 4.5MM DIST FEM PL R 17H 342MM PLATE. AS A CONSEQUENCE OF THIS ISSUE THE AFFECTED FEMUR STARTED TO COLLAPSE. IT APPEARS A REVISION SURGERY HAS BEEN CONDUCTED BUT THIS INFORMATION IS YET TO BE CONFIRMED. THERE IS NO FURTHER INFORMATION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 17977315 ↗
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-0364-2022 · Nov 1, 2021 · Terminatedsmith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
- Z-0365-2022 · Nov 1, 2021 · Terminatedsmith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
- Z-0366-2022 · Nov 1, 2021 · Terminatedsmith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
- Z-0363-2022 · Nov 1, 2021 · Terminatedsmith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
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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