EVOS 72572212NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556753927), received between Jul 12, 2024 and Jul 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, AFTER EVOS ORIF SURGERY FOR FEMORAL AND NECK FRACTURE THAT HAD BEEN PERFORMED ABOUT 5 MONTHS AGO, ONE (1) EVOS 4.5MM PROX FEM PL 12H R 280MM REPORTEDLY BROKE PROXIMALLY AS RESULT OF BONES NOT HEALING. THE FRACTURE WAS FIRST TREATED WITH THE INSERTION OF NAIL, BUT IT WAS REMOVED AS IT FAILED TO UNITE, SO IT WAS CONVERTED TO THE EVOS FIXATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INTERNAL FIXATION WAS CONVERTED TO THR. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19731045 ↗

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 · Terminated
  smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
• Z-0366-2022 · Nov 1, 2021 · Terminated
  smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
• Z-0365-2022 · Nov 1, 2021 · Terminated
  smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
• Z-0363-2022 · Nov 1, 2021 · Terminated
  smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101