BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER ACETUBULAR SYSTEM

    MDR report key: 3944571 · Received July 14, 2014

    Report

    Report Number
    MW5037278
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    January 10, 2008
    Report Date
    July 3, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ZIMMER ACETABULAR SYSTEM INSERTED IN LEFT HIP IN (B)(6) 2008. ON (B)(6) 2012 SUFFERED 1ST DISLOCATION. THERE WAS 5 MORE DISLOCATIONS PRIOR TO REVISION AT (B)(6) HOSPITAL ON (B)(6) 2013. AT TIME OF TOTAL JOINT REVISION FOUND METAL ON METAL. COVERING AT ZIMMER HAD WORN CAUSING METAL FLAKING 5 YEARS AFTER HIP IMPLANT SYSTEM BEGAN FAILING CAUSING SEVERE PAIN AND 6 DISLOCATIONS RESULTING IN TRIPS TO EMERGENCY ROOM. HAD TO HAVE REVISION ON (B)(6) 2013 AT (B)(6) HOSPITAL IN (B)(6). DOCTOR FOUND METAL FLAKES AT CHROMIUM AND TITANIUM ON BLOOD SYSTEM. DOCTOR PUT IN NEW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410125 ZIMMER ACETUBULAR SYSTEM HIP REPLACEMENT LPH ZIMMER INC TRILOGY 60823203

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R