BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2772183 · Received October 4, 2012

    Report

    Report Number
    1818910-2012-75696
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    December 29, 2011
    Report Date
    September 4, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN, DISABILITY, AND EXPOSURE TO CHROMIUM AND COBALT. THE PATIENT HAD SEVERAL ADDITIONAL SURGICAL PROCEDURES TO HER RIGHT HIP FOLLOWING THE ASR EXPLANTATION DUE TO INFECTION RELATED TO THE ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2246154

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention