BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 1923658 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-09412
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    May 4, 2010
    Report Date
    November 9, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    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/BROADSPIRE 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 ACETABULAR LOOSENING WITH MODERATE OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2281790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention