BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMACUP SC PLASMAPORE

    MDR report key: 1031586 · Received March 7, 2008

    Report

    Report Number
    3005673311-2007-00033
    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 XRAYS. ACETABULAR CUP HAS ROTATED. NO ACETABULAR SCREWS WERE USED WITH THE CUP ORIGINAL SURGERY DATE: 2007; DISPLACEMENT: THREE DAYS LATER; REVISION SURGERY: TWO DAYS AFTER. PATIENT: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMACUP SC PLASMAPORE NONE KWB AESCULAP AG & CO. KG NC460T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other