BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 52

    MDR report key: 1790079 · Received August 5, 2010

    Report

    Report Number
    1818910-2010-05111
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 NECROTIC TISSUE IN THE JOINT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 52 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2765181

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention