BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 36MM+6

    MDR report key: 2232814 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-14688
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    PATIENT HAD PAIN FOR SEVERAL MONTHS, GRADUALLY INCREASING, THEN THE HIP WAS SUDDENLY DISLOCATED, CUP LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 11/13 36MM+6 87KWA, LZO KWA DEPUY INTERNATIONAL, LTD. NA 3196099

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention