BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CORAIL STEM SYSTEM

    MDR report key: 1953647 · Received January 4, 2011

    Report

    Report Number
    MW5018893
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    April 24, 2009
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A TOTAL RIGHT HIP REPLACEMENT ON (B)(6), 2009 BY DOCTOR (B)(6) AT (B)(6) MED CTR. THE SYSTEM USED WAS A DEPUY CORAIL STEM, SIZE 12 WITH A STANDARD +8.5, 36MM CERAMIC HEAD BALL. CUP USED WAS A 52 PINNACLE SECTOR CUP WITH ULTREX POLYETHYLENE LINER. I HAVE EXPERIENCED PAIN IN THE RIGHT HIP AREA EVER SINCE THE OPERATION. DR (B)(6) PUT ME ON PHYSICAL THERAPY A COUPLE OF TIMES, PRESCRIBED INJECTIONS -PERFORMED BY DR (B)(6) AT (B)(6)- AND A CT SCAN. DR (B)(6) WAS NOT SURE WHAT WAS CAUSING THE PAIN BUT HE INSISTED IT WAS NOT THE HIP. MY HIP NEVER IMPROVED UNDER HIS CARE. I WENT TO SEE DR (B)(6) OF (B)(6) THIS PAST SPRING FOR A SECOND OPINION. HE INJECTED CORTISONE DIRECTLY INTO THE JOINT WHICH WAS NOT DONE PREVIOUSLY AND IT HELPED A LITTLE. HOWEVER, HE HAD A DIFFICULT TIME IN INSERTING THE NEEDLE INTO THE HIP JOINT BECAUSE THERE WAS A LOT OF BUILDUP -PLAQUES-. HE SAID THAT I WOULD NEED ANOTHER OPERATION TO REMOVE THE BUILDUP BUT COULD NOT GUARANTEE THAT THE PAIN WOULD BE ALLEVIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY CORAIL STEM SYSTEM HIP REPLACEMENT KWA DEPUY
    2 ULTREX POLYETHLYLENE LINER HIP REPLACEMENT KWA DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization