AXSOS 627646SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540685780), received between Sep 14, 2020 and Dec 16, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

• InjuryDec 16, 2025Fracture; Fracture

  THE FOLLOWING INFORMATION WAS REPORTED: AXSOS FEMUR PLATE BROKE AFTER FIXATION OF FEMUR FRACTURE. REVISION SURGERY NEEDED AFTER THE PLATE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 23818020 ↗
• InjuryJun 18, 2025Break; Fracture; Break; Fracture

  AS REPORTED BY THE REP: "RAQA PURPOSE: SURGEON WOULD LIKE THE STRYKER ENGINEERS TO TAKE A LOOK AT A REMOVED PLATE ONCE DECONTAMINATED AND RETURNED. PATIENT INFO: HAS A HIP REPLACEMENT, TOTAL KNEE REPLACEMENT AND AXSOS 5MM DLF WITH DALL MILES CABLES. SURGEON REPORTS PATIENT HAD HIP REPLACEMENT AND KNEE REPLACEMENT PREVIOUSLY. PATIENT THEN FELL OVER IN MARCH THIS YEAR AND FRACTURED THE FEMUR, REQUIRING AN AXSOS DLF PLATE. MORE RECENTLY, PATIENT HAS FALLEN AGAIN AND SUBSEQUENTLY REQUIRED TODAY¿S SURGERY FOCUS ITEM: AXSOS 3 5MM SYSTEM, DISTAL LATERAL FEMORAL PLATE, TITANIUM. 16 HOLE. SHAFT IS AFFECTED AT APPROX. 4TH HOLE ABOVE THE OBLONG HOLE. PLATE INSERTION CASE DATE: (B)(6) 2025 LOCATION: (B)(6). REMOVAL CASE DATE: (B)(6) 2025 LOCATION: (B)(6) TIME: APPROX. 1PM TO 6:30PM. PURPOSE OF CASE TODAY: REMOVE AFFECTED AXSOS PLATE AND SCREWS, INSERT AN ALPHA RETROGRADE NAIL AND A NEW AXSOS DLF 16 HOLE. KITS USED TODAY: AXSOS 3 5MM, T2 ALPHA RETROGRADE INDICATION, T2 ALPHA BASIC IMN. ALL CONSIGNED INSTRUMENT KITS (NOT LOANED)."

  Patient problems: Fall

  MAUDE report 22287495 ↗
• InjurySep 14, 2020Fracture; Fracture

  AS REPORTED: "REVISION OF BROKEN AXSOS3 DISTAL FEMORAL PLATE 16 HOLE RIGHT." "PLATE REVISED WITH NEW DISTAL FEM PLATE AND SECOND PLATE AND BONE GRAFT." PATIENT WAS FOUND TO HAVE NON-UNION.

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

  MAUDE report 10532047 ↗