BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 1842518 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06731
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LZO
    PMA / PMN Number
    K031803
    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

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 12/14 36MM +1.5 87LZO LZO DEPUY INTERNATIONAL, LTD. NA 3043393

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention