BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2011442 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03584
    Event Type
    Injury
    Date Received
    March 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES AND CONTINUES TO SUFFER FROM INJURIES AND DAMAGES OF A PERMANENT AND LASTING NATURE AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP NONE KWA DEPUY INTERNATIONAL, LTD NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention