BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDULLARY CEMENT PLUGS

    MDR report key: 1003230 · Received February 21, 2008

    Report

    Report Number
    1822565-2008-00062
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT EXPERIENCED EXTREME DECREASE OF BLOOD PRESSURE AFTER TOTAL HIP ARTHROPLASTY SURGERY. POST-OP X-RAYS SHOWED THE BONE PLUG AND BONE CEMENT FALLING DOWN TO DISTAL OF THE MARROW CAVITY. THE PATIENT GOT WELL, AND THE SURGEON DID NOT PERFORM ANY ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDULLARY CEMENT PLUGS MEDULLARY CEMENT PLUG LOD ZIMMER, INC. NA 60471449

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK