BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 17009 · Received July 20, 1994

    Report

    Report Number
    17009
    Event Type
    Injury
    Date Received
    July 20, 1994
    Date of Event
    May 15, 1993
    Report Date
    March 8, 1994
    Manufacturer
    ZIMMER
    Product Code
    KWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    12/10/87 - PAT. HAD LEFT TOTAL HIP REPLACEMENT. SEVERAL FEET WHEN THE LADDER HE WAS STANDING ON BROKE - SUDDEN ONSET OF PAIN IN LEFT LEG. X-RAYS SHOWED A FRACTURED STEM OF THE HYBRED PROSTHESIS ON THE LEFT HIP.7/22/93 - PT. UNDERWENT REVISION OF LEFT TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant HARRIS PRECOAT FEMORAL STEM KWL ZIMMER 60051900

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention HARRIS/GALANTE POROUS TOTAL HIP ACETABULAR| COMPONENT, ZIMMER CANCELLOUS BONE SCREW SELF| TAPING 30MM LENGTH AND 25MM LENGTH, ZIMMER FEMORAL| HEAD.