BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS BONE CEMENT

    MDR report key: 23222215 · Received October 6, 2025

    Report

    Report Number
    MW5176935
    Event Type
    Injury
    Date Received
    October 6, 2025
    Report Date
    October 1, 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

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN LEFT KNEE. DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. 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
    2279003 PALACOS BONE CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC. 95034979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown