BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS CEMENT

    MDR report key: 23932899 · Received December 30, 2025

    Report

    Report Number
    MW5181522
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 22, 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, DEPUY SYNTHES NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-DEPUY SYNTHES PRODUCT. CLINICAL ADVERSE EVENT RECEIVED FOR BILATERAL LEG CELLULITIS - WORSE ON LEFT LEG. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: DEFINITELY NOT. 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
    2708212 PALACOS CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC 67681283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown