BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3081234 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-01482
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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: PAIN, LIMPING, MUSCLE LOSS AND TISSUE DESTRUCTION. DOI: (B)(6) 2009 LEFT HIP. DOR: NONE REPORTED. PATIENT RESIDENCE: (B)(6). UPDATE (B)(6) 2013 - ASR/SUPPLEMENTAL RECEIVED. PART/LOT HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182552 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2442983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O