BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE TITANIUM STEM LEFT

    MDR report key: 4025014 · Received August 15, 2014

    Report

    Report Number
    MW5037786
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 14, 2014
    Manufacturer
    DEPUY
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2010 BOTH HIPS WERE REPLACED WITH PINNACLE TITANIUM STEM, BIOLOX DELTA ARTICUL/EZE CERAMIC HEAD, PINNACLE 100 ACETABULAR SHELL (TITANIUM CUP). HIPS FEEL ODD FEAR OF DISLOCATION. MRI OF BOTH HIPS SHOWED FLUID FILLED SACS THAT ARE PUSHING MUSCLES OUT OF PLACE, HENCE ODD FEELING. BLOOD WORK SHOWED METAL ION LEVELS "WAY TOO HIGH" ACCORDING TO MY SURGEON. I HAVE TO HAVE SURGERY TO CHANGE COMPONENTS TO DECREASE METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491443 PINNACLE TITANIUM STEM LEFT HIP REPLACEMENT STEM LPH DEPUY
    491444 BIOLOX DELTA ARTICUL/EZE CERAMIC HEAD LEFT HIP REPLACEMENT CERAMIC HEAD LZO DEPUY
    491445 PINNACLE ACETABULAR SHELL RIGHT HIP REPLACEMENT SHELL LPH DEPUY 1217-31-060 ED2PL1
    491446 PINNACLE TITANIUM STEM RIGHT HIP REPLACEMENT STEM LPH DEPUY
    491447 BIOLOX DELTA ARTICUL/EZE CERAMIC HEAD RIGHT HIP REPLACEMENT CERAMIC HEAD LZO DEPUY
    491537 PINNACLE ACETABULAR SHELL LEFT HIP REPLACEMENT SHELL LPH DEPUY 1217-31-060 ED2PL1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other