BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R BONE CEMENT WITH GENTAMICIN

    MDR report key: 17799850 · Received September 21, 2023

    Report

    Report Number
    MW5146047
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Report Date
    September 20, 2023
    Manufacturer
    ZIMMER BIOMET/ZIMMER, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, DEPUY SYNTHES JOINT RECONSTRUCTION NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCT. REFERENCE REPORT: MW5146048. 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
    1071389 PALACOS R BONE CEMENT WITH GENTAMICIN BONE CEMENT LOD ZIMMER BIOMET/ZIMMER, INC. 66017569 88984669

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown