BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 2852772 · Received November 30, 2012

    Report

    Report Number
    1818910-2012-25362
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    August 30, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    PATIENT

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    ASR REVISION ASR XL - LEFT HIP; REASON(S) FOR REVISION: PAIN; COMPONENT MALALIGNMENT; DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 46 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2523033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention