BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NATURAL HIP SYSTEM

    MDR report key: 1981313 · Received January 26, 2011

    Report

    Report Number
    MW5019295
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    March 19, 2006
    Report Date
    January 21, 2011
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FIRST HIP IMPLANT (B)(6) 2006, BEGAN TO LOOSEN AFTER A FEW MONTHS, BECAUSE THE PRODUCT USED TO HOLD THE IMPLANT IN PLACE BEGAN TO FALL APART. ANOTHER SURGERY ATTEMPT WAS MADE ON (B)(6) 2008, TO REPLACE THE IMPLANT. AT THAT POINT, THERE WAS SUCH A BAD INFECTION, THAT THEY HAD TO CLOSE THE INCISION AND BEGAN A PIC-LINE TO LET IT HEAL. FINALLY, ON (B)(6) 2008, A SECOND IMPLANT WAS COMPLETED. THE INCISION CONTINUED TO DRAIN, AND WOULD NOT HEAL. ON (B)(6) 2008, A FOURTH AND FINAL SURGERY WAS DONE TO FLUSH AND PLACE A DRAIN. THERE WAS A DELAY IN MAKING ANY KIND OF REPORT OR INQUIRY OF THIS DUE TO THE ON GOING ILLNESS SURGERIES HOSPITAL STAYS AND STRESS. AND I HAD NO ONE ELSE TO TAKE CARE OR ANY PROBLEMS FOR ME. MY HUSBAND HAD JUST PASSED AWAY A FEW WEEKS PRIOR TO MY FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NATURAL HIP SYSTEM HIP IMPLANT JDI ZIMMER NA 1659371
    2 CENTERPULSE ORTHOPEDICS INC. HIP IMPLANT JDI CENTERPULSE ORTHOPEDICS INC. NA 1643737
    3 SULZER ORTHOPEDICS HIP IMPLANT JDI SULZER ORTHOPEDICS NA 1530368
    4 MICROTEK CEMENT RESTRICTOR JDK MICROTEK NA C6160
    5 SURGICAL SIMPLEX RADIO PAQUE BONE CEMENT LOD STRYKER NA RDN109

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S