BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2142740 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-10874
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT SIDE ON OR ABOUT (B)(6) 2008. SINCE HIS SURGERY, PT HAS EXPERIENCED GRINDING IN THE LEFT HIP AREA. PT HAS NOT YET SCHEDULED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 KWA KXA DEPUY INTERNATIONAL, LTD. NA 2762108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention