BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 17011 · Received July 20, 1994

    Report

    Report Number
    17011
    Event Type
    Injury
    Date Received
    July 20, 1994
    Date of Event
    November 13, 1993
    Report Date
    March 8, 1994
    Manufacturer
    ZIMMER
    Product Code
    JDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    7/17/89 - PT. HAD LEFT TOTAL HIP REPLACEMENT12/13/93 - PT. REPORTS ABOUT 1 MONTH AGO HE BEGAN HAVING SEVERE PAIN IN THE LEFT THIGH X-RAYS SHOW A FRACTURED HARRIS CEMENTED FEMORAL COMPONENT WHICH HAS FRACTURED AT THE UNCTION OF THE DISTAL AND MIDDLE THIRDS OF THE STEM.2/14/93 - 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 JDD ZIMMER 65174600

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention HARRIS/GALANTE POROUS TOTAL HIP ACETABULAR| RESTRICTOR.| COMPONENT, ZIMMER CANCELLOUS BONE SCREW SELF| TAPING, ZIMMER FEMORAL HEAD DEPUY FEMORAL CEMENT