BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY1 GENTAMICIN CEMENT 40G

    MDR report key: 1080927 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02997
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    DEPUY CMW
    Product Code
    MBB
    PMA / PMN Number
    K053002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF LOOSENING WITH THE CEMENT BREAK DOWN AT THE BONE/CEMENT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY1 GENTAMICIN CEMENT 40G 87MBB; 87LOD MBB DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention