BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 40MM +8.5

    MDR report key: 2012544 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-03014
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    DEPUY INT'L., LTD.
    Product Code
    LZO
    PMA / PMN Number
    K073570
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLT TS CER HD 12/14 40MM +8.5 87LZO LZO DEPUY INT'L., LTD. NA 3062802

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention