BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE METAL ON METAL HIP

    MDR report key: 8366345 · Received February 21, 2019

    Report

    Report Number
    MW5084283
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    April 21, 2018
    Report Date
    February 17, 2019
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED A METAL ON METAL HIP REPLACEMENT 2006, WENT FOR 12 YEARS TO MULTIPLE DOCTORS WHO REFUSED TO TAKE CARE OF ME. SEVERE WORSENING PAIN FROM THE DAY IT WAS PLACED UNTIL (B)(6) 2018. IN THIS TIME I EXPERIENCED PAIN, NEUROPATHY, RASHES, ITCHING, ANXIETY, DEPRESSION, COGNITIVE ISSUES, MADE FUN OF FOR YEARS BECAUSE OF THE NOISES THE HIP MADE WITH EVERY STEP. ALL DOCTORS EVER DID WERE X-RAYS AND THEY ALWAYS STATED THE HIP WAS IN PLACE. THE FDA ALLOWED THIS DEVICE INTO THE MARKET AND I HAVE BEEN SEVERELY INJURED AND HAVE LIFELONG DISABILITIES BECAUSE OF THIS METAL ON METAL HIP. NOW COMPLETELY UNABLE TO RETURN TO MY CAREER AS A REGISTERED NURSE. METAL LEVELS OVER 49, SEPSIS, PSEUDOTUMORS, NECROSIS AND BONE LOSS. ANTIBIOTIC SPACER PLACED (B)(6) 2018 FOR OVER 8 MONTHS AND REVISION ON (B)(6) 2018. ALL COMPLETED AT (B)(6) MEDICAL CENTER, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153906 PINNACLE METAL ON METAL HIP PROSTHESIS, HIP LPH DEPUY SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R| S