Alteon 01-010-24-4245Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862282187), received between Apr 10, 2020 and Apr 10, 2020 — classified as 1 injury.

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 18, 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.

• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) Y/O FEMALE WEIGHT (B)(6) LBS AND A HISTORY OF HYPERTENSION WAS INITIALLY IMPLANTED WITH A THA. THE PATIENT PRESENTED WITH A PERIPROSTHETIC FEMORAL FRACTURE APPROXIMATELY 4 DAYS POSTOP THAT WAS DESCRIBED AS A CONFLICT BETWEEN FEMORAL STEM AND FEMORAL DIAPHYSIS IS IDENTIFIED WITH LINEAL FRACTURE FROM TIP OF STEM. THE REVISION PROCEDURE WAS AN AUGMENTATION OF FEMUR DIAPHYSIS WITH PLATE RESOLUTION. THE PATIENT WAS DISCHARGED WITH A WALKER TO A RELATIVE¿S HOME ON 1 DAY POSTOP. DEVICES WILL NOT BE RETURNED AS THIS IS A CLINICAL STUDY PATIENT. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. NOTE THE PATIENT ENTERED THE STUDY ON (B)(6) 2020 WITH A REVISION OF EXACTECH DEVICES DUE TO ASEPTIC LOOSENING. CASE (B)(4) HAS BEEN OPENED TO CAPTURED THIS REVISION.

  Patient problems: Bone Fracture(s)

  MAUDE report 9947879 ↗