BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2002799 · Received February 17, 2011

    Report

    Report Number
    1818910-2011-01090
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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

    PT WAS REVISED TO ADDRESS PAIN IN HIP AND DOWN TO KNEE. PT HAD ELEVATED PLASMA CHROMIUM AND COBALT LEVELS IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2509667

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention