Alteon 01-010-16-4195Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862281876), received between Apr 13, 2020 and Apr 13, 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 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT¿S INITIAL THA WITH A COMPETITOR¿S DEVICES IN 2005. ON (B)(6) 2019, THIS 44 Y/O FEMALE PATIENT, WEIGHT 171 LBS., EXPERIENCED A PREVIOUS REVISION OF ANOTHER MANUFACTURER¿S DEVICES DUE TO ASEPTIC LOOSENING. ON (B)(6) 2020, THE PATIENT UNDERWENT AN ARTHROCENTESIS DUE TO THE APPEARANCE OF A HEMATOMA ON (B)(6) 2020. THE PATIENT CONTINUED WITH PAIN AND DIFFICULT MANAGEMENT. ELEVEN DAYS LATER, FRANK PUS WAS OBSERVED AND THE HOSPITAL¿S ¿PROSTHESIS RETENTION PROTOCOL FOR PERI-PROSTHETIC INFECTION¿ IS STARTED, ANTIBIOTIC MANAGEMENT IS STARTED, AND THE PATIENT IS STILL HOSPITALIZED. THE PATIENT WAS TAKEN FOR MORE ¿WASHOUTS¿ ON (B)(6) 2020. ON (B)(6), PREVIOUSLY INSERTED HEMOVAC DRAIN WAS REMOVED. ON (B)(6) 2020, THIS PATIENT UNDERWENT A REVISION FOR INFECTION, WHICH INCLUDES THIS MANUFACTURER¿S DEVICES.

  Patient problems: Bacterial Infection

  MAUDE report 9953115 ↗