BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 54

    MDR report key: 1210550 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-05048
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    November 1, 2007
    Report Date
    September 3, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER, SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. 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

    REVISION DUE TO PAIN AND 'CATCHING' ON CERTAIN MOVEMENT OF THE HIP WHICH HAD OCCURRED SINCE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 54 TOTAL HIP REPLACEMENT KWB DEPUY INTERNATIONAL, LTD. N/A 1896274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention