BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCIA PLASMAPORE-CAP 8/

    MDR report key: 1031589 · Received March 7, 2008

    Report

    Report Number
    3005673311-2007-00036
    Event Type
    Injury
    Date Received
    March 7, 2008
    Date of Event
    July 30, 2007
    Report Date
    September 10, 2007
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGERY TO REVISE ACETABULAR CUP DUE TO MALALIGNMENT. PATIENT UNDERWENT PRIMARY CEMENTLESS ARTHROPLASTY ON RIGHT HIP. THREE DAYS AFTER SURGERY, PATIENT HEARD A SNAP AND PAIN. PATIENT STATED THAT THEY WERE NOT "MOVING AS WELL AS THIS MORNING AND IT HURTS MORE". PATIENT ADMITS TO POSSIBLY OVERDOING ACTIVITY. SURGEON ORDERED X-RAYS. ACETABULAR CUP HAS ROTATED. NO ACETABULAR SCREWS WERE USED WITH THE CUP ORIGINAL SURGERY DATE:2007; DISPLACEMENT: THE NEXT DAY; REVISION SURGERY TWO DAYS LATER. PATIENT: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCIA PLASMAPORE-CAP 8/ NONE KWB AESCULAP AG & CO. KG NC412T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other