EVOS 72585216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556771112), received between Oct 20, 2023 and Sep 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A PERIPROSTHETIC FRACTURE FIXATION RIGHT SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT HAD A FALL AND ONE (1) EVOS 3.5/4.5 PP PROX FEM PL R 16H 329MM SNAPPED IN HALF NOT FAR FROM FRACTURE CLEAN SNAP THROUGH THE PLATE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE EVOS 3.5/4.5 PP PROX FEM PL R 16H 329MM WAS EXPLANTED. THE PATIENT IS REPORTEDLY RECOVERING AND DISCHARGED.

  Patient problems: Fall; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23086552 ↗
• InjuryDec 4, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, A SUSTAINED RIGHT FEMORAL SHAFT DISTAL FRACTURE WAS PRODUCE DUE TO A FALL FROM STANDING HEIGHT AFTER SLIPPING ON THE BATHROOM FLOOR, THUS, A SURGERY HAD BEEN PERFORMED ON (B)(6)2024. ON (B)(6)2024 THE PATIENT DEVELOPED NEW ONSET PROGRESSIVE PAIN AND SWELLING RIGHT THIGH WHEN MOBILIZING. X-RAYS WERE REQUESTED, WHICH SHOWED THAT THE EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM BROKEN AND BENT ALONG THE 7TH HOLE BUT WAS STILL PARTIALLY ATTACHED. THE AFFECTED HOLE OF PLATE HAD A 4.5 MM CORTICAL LAG SCREW INSERTED THROUGH THE HOLE INTO A LONG SPIRAL FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE DEVICE WAS EXPLANTED AND A REVISION FIXATION WITH RETROGRADE FEMORAL NAIL AND A SMITH AND NEPHEW EVOS LARGE FRAGMENT PLATE AS DUAL CONSTRUCT. CURRENT HEALTH STATUS OF PATIENT IS CONTINUING REHABILITATION, PROGRESSING WELL, THEY HAVE BEEN MOBILIZING FULL WEIGHT BEARING AS TOLERATED IN THE POST-OPERATIVE PERIOD AND REMAINS UNDER REVIEW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 20843365 ↗
• InjuryOct 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED, THE LOCKING SCREWS STARTED TO BACK OUT OF THE LOCKING HOLES ON THE EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE TO SOLVE THE ADVERSE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 17977172 ↗