AXSOS 627644Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252579687), received between Dec 19, 2018 and Jul 9, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Break; Fracture; Break; Fracture

  A S REPORTED: "WE HAD A REVISION CASE TO REMOVE A BROKEN AXSOS 3 TITANIUM DISTAL LATERAL FEMUR PLATE".

  Patient problems: Insufficient Information

  MAUDE report 22461507 ↗
• InjuryMay 1, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT: "THE PATIENT HAD A FRACTURE ON A KNEE PROSTHESIS IN (B)(6) 2023 OPERATED WITH AN AXSOS FEMUR PLATE. SHE FELL AT HOME AND BROKE HER AXSOS PLATE. THE PATIENT REQUIRED A REVISION SURGERY WITH A NEW AXSOS FEMUR PLATE AND BONE GRAFT."

  Patient problems: Failure of Implant; Fall

  MAUDE report 19225062 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED. AFTER A PREVIOUS ORIF TO ADDRESS A FEMORAL FRACTURE, PATIENT PRESENTED COMPLAINING OF PAIN AND LIMITED ROM. X-RAY SHOWED NON-UNION OF THE BONE WITH 3 BROKEN SCREWS AND ONE SCREW WHICH PULLED OUT WITH THE PLATE. A FEMORAL STEM AND HEAD, THE PLATE AND SCREWS, AND A COMPETITOR KNEE WERE REVISED TO A COMPETITOR TOTAL FEMUR REPLACEMENT (ACETABULAR COMPONENTS WERE LEFT IN SITU). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Implant Pain; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17124169 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO PUSSING OUT, THE LATERAL LOCKING PLATE WAS REMOVED, AND ANTIBIOTIC BEADS WERE PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 16453273 ↗
• InjuryFeb 3, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A T2 ALPHA RETROGRADE AND AXSOS DISTAL LATERAL FEMUR PLATE FAILED RESULTING IN A REVISION.

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

  MAUDE report 16294258 ↗
• InjuryMar 4, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available; Fracture

  AS REPORTED ON MAUDE REPORT MW5077828-1 " PATIENT HAD A SECOND REVISION DUE TO BROKEN PLATE. INTERNAL FEMORAL ROD WAS IMPLANTED."

  Patient problems: No Code Available; No Information

  MAUDE report 8388720 ↗
• InjuryDec 19, 2018Break

  AS REPORTED: "CAME IN TO COVER CASE FOR LONG GAMMA NAIL, WAS TOLD PATIENT HAD A DISTAL LATERAL FEMUR PLATE THAT BROKE. PATIENT ALSO HAD SHORT GAMMA NAIL IN. EXPLANTED FEMUR PLATE AND SHORT GAMMA NAIL. PUT IN LONG GAMMA NAIL. WHEN TRYING TO OBTAIN INFORMATION I WAS TOLD FAMILY HAD TAKEN THE FEMUR PLATE."

  Patient problems: No Code Available

  MAUDE report 8182723 ↗