BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 3212069 · Received July 8, 2013

    Report

    Report Number
    1818910-2013-20701
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    October 28, 2011
    Report Date
    June 21, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ASR REVISION;ASR XL - LEFT;REASON(S) FOR REVISION: PAIN.THIS IS THE 2ND OF 2 REVISIONS. (B)(4).IMPLANT DATE OF CUP: (B)(6) 2008.IMPLANT DATE OF XL PRODUCTS HEAD, STEM AND TAPER SLEEVE: (B)(6) 2009.ALL PRODUCTS WERE REVISED ON THE (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309256 DEPUY ASR XL FEM IMP SIZE 47 FEMORAL HEAD KXA DEPUY INTL., LTD. - 8010379 2752298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention