BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULLAR ACETABULAR SY

    MDR report key: 1170172 · Received September 21, 2008

    Report

    Report Number
    MW5008373
    Event Type
    Injury
    Date Received
    September 21, 2008
    Date of Event
    June 8, 2006
    Report Date
    September 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A WOMAN AND HAVE A ZIMMER ACETABULAR IMPLANT SET-TOTAL SYSTEM - FOR TOTAL HIP REPLACEMENT IN MY LEFT HIP PLUS IN BOTH OF MY HIPS. IT HAS BEEN TWO YEARS. I AM EXPERIENCING CONSTANT GRINDING IN THE LEFT HIP CUP AND A LOOSENING WHEN I WALK. I HAVE BEEN TO MY DOCTOR AND I HAVE UNDERGONE THE FLUID EXTRACTION FOR INFECTION AND TESTS AND MANY XRAYS. I SUFFERED MUCH TRAMA FROM MY OPERATION DUE TO A FEMUR FRACTURE. I AM TOLD THAT HE AND OR HIS TWO OTHER COLLEAGUES WILL NOT OPERATE AND THAT I AM BETTER OF JUST LEAVING IT THIS WAY. I HAVE DAILY POPPING AND GRINDING WHEN I WALK. I FEEL IT IS IMPERATIVE THAT I FIND OUT IF THIS TYPE OF HIP IMPLANT SET HAS BEEN RECALLED. I READ THAT THE DUROM CUP IS BEING RECALLED AND I HAVE THE SAME IDENTICAL SYMPTOMS. I FEEL STUCK. MY DOCTOR WILL NOT REFER ME TO ANOTHER FACILITY I WANT TO GO, SO I CAN GET MY PROBLEM TAKEN CARE OF. THAT IS THE ONLY WAY THEY WILL SEE ME. I NEED TO REPORT THAT ZIMMER, ACETABULAR TOTAL HIP IMPLANT SYSTEM IS DEFECTIVE ONLY AFTER TWO YEARS. I FEAR THAT I WILL EXPERIENCE FURTHER DAMAGE AND HEALTH ISSUES DUE TO THE PROBLEMS I AM HAVING. I AM WORRIED ABOUT BECOMING CRIPPLE. HELP. PLEASE HELP ME FIND OUT AND DIRECT ME IN WHAT I SHOULD DO. I DON'T WANT ANY OTHER PEOPLE TO GO THROUGH WHAT I AM GOING THROUGH. RECAP: HAS THE ZIMMER ACETABULAR SYSTEM BEEN RECALLED OR IS IT BEING INVESTIGATED? HELP! IN 2006, THE ZIMMER IMPLANT SYSTEM WAS PLACED IN MY LEFT HIP. FOUR MONTHS PRIOR, I HAD THE RIGHT HIP IMPLANTED WITH THE SAME DEVICE SYSTEM. PLEASE SEE PREVIOUS COMMENTS REGARDING THIS DEVICE MADE BY ZIMMER, INC. I AM NOT SURE WHAT YOU NEED HERE HOWEVER, I UNDERWENT PHYSICAL THERAPY RIGHT AFTER THE OPERATION AND WAS DOING WELL UNTIL 2007. THE DEVICE BEGAN FEELING LOOSE AND BEGAN SLIPPING WHEN I WALKED. IT HAS ESCALATED TO A CHRONIC SLIPPING AND GRINDING WHEN I WALK. I AM UNABLE TO GET THE MEDICAL ATTENTION I NEED DUE TO MY DOCTORS REFUSAL TO BELIEVE I HAVE A PROBLEM. THE DEVICE APPEARS TO BE SEATED WELL ON XRAY AND I AM STRUGGLING DAILY. THIS SYSTEM IS A PROBLEM!!! ROUTE: OTHER. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: HIP DYSPLASIA IN RIGHT AND LEFT HIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULLAR ACETABULAR SY TRABECULAR ACETABULAR SYSTEM HIP IMPLANT TOTAL SYSTEM KWB ZIMMER, INC. TREBECULLARMETAL 60469781
    2 ZIMMER TRABECULLAR ACETABULAR SY FEMOR KWY ZIMMER, INC. 603468498
    3 ZIMMER TRABECULLAR STEM KWY ZIMMER, INC. 60077802

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR