BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2151326 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11838
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PT WAS REVISED TO ADDRESS PAIN. THE REVISION OPERATIVE REPORT STATES THAT THE PT HAD SIGNIFICANT BROWN STAINING OF THE SURROUNDING SYNOVIUM AND SIGNIFICANT CHRONIC GRANULOMATOUS TYPE OF REACTION GOING DOWN TOWARDS THE INFERIOR REGIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1984942

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention