BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY HV BONE CEMENT

    MDR report key: 1902204 · Received November 15, 2010

    Report

    Report Number
    1818910-2010-08229
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 17, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    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

    PT REVISED FOR INFECTION AND LOOSE TIBIA AT BOTH IMPLANT/CEMENT AND CEMENT/BONE INTERFACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY HV BONE CEMENT 87 LOD LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention