BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS MV+G 1X40 BONE CEMENT

    MDR report key: 22047211 · Received May 19, 2025

    Report

    Report Number
    MW5170582
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    May 28, 2024
    Report Date
    May 15, 2025
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR TOTAL KNEE ARTHROPLASTY LEFT. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY RELATED. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: 20 MAY 2025. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT KNEE. TREATMENT/IMPACT: RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY STRUCTURE OR A BODY FUNCTION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77449 PALACOS MV+G 1X40 BONE CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC 66031993 94644761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown