BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN REVISION 40 -3

    MDR report key: 23605479 · Received November 20, 2025

    Report

    Report Number
    MW5179150
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    November 26, 2022
    Report Date
    November 18, 2025
    Manufacturer
    BIOMET FRANCE
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FULL KNEE REVISION USING ATTUNE PS RP OPERATIVE SIDE: LEFT DATE OF SURGERY: (B)(6) 2019. EVENT DESCRIPTION (DIAGNOSIS): INFECTED BILATERAL LEG ULCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489745 REFOBACIN REVISION 40 -3 BONE CEMENT LOD BIOMET FRANCE 820BAL1107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown