BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ASR HEAD

    MDR report key: 3920325 · Received July 8, 2014

    Report

    Report Number
    1818910-2014-22962
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KXA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION REPORTED BY SALES REP, RIGHT, REASON(S) FOR REVISION: UNKNOWN. ASR REVISION. ASR WAS CEMENTED INTO A 74MM TM REVISION SHELL (ZIMMER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397424 UNIDENTIFIED ASR HEAD HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD.-8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention