BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 3191606 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19947
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    August 19, 2009
    Report Date
    April 15, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL ACETABULAR SYSTEM - RIGHT, REASON(S) FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED).

    Description of Event or Problem · 1

    ASR REVISION.ASR XL ACETABULAR SYSTEM - RIGHT.REASON(S) FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED).UPDATE 17 APRIL 2015:UPDATING DETAILS FOR STEM AND SLEEVE.LOT NUMBERS NOT AVAILABLE..(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291599 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD KXA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention