BEUDAMED
    FDA Adverse Event Other Summary report: N

    BI-METRIC LATZ 9X125

    MDR report key: 2398442 · Received December 29, 2011

    Report

    Report Number
    MW5023680
    Event Type
    Other
    Date Received
    December 29, 2011
    Date of Event
    May 4, 2009
    Report Date
    December 29, 2011
    Manufacturer
    BIOMED
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LGC HAD A RIGHT HIP REPLACEMENT WITH A BI-METRIC LATZ 9X125 -R-HIP SIZE MM X 125 MM MODEL X11-180309 AND A M2A MAGNUM PF CUP 54 MODEL US15854 ON (B)(6) 2009. THE HIP NEVER FUNCTIONED PROPERLY IN THAT THERE WAS PAIN IN THE HIP AREA AND BALANCE ISSUES. SHE WAS GIVEN A SHOT FOR BURSITIS, WHICH EASED THE PAIN FOR A SHORT LENGTH OF TIME. THE PAIN CONTINUED AND SHE COMPLAINED OF THE HIP COMING OUT OF THE SOCKET AND OF A GRINDING NOISE. SHE WENT TO SEE ANOTHER SURGEON IN (B)(6) 2011. SHE WAS TOLD OF PROBLEMS WITH METAL ON METAL HIP AND WAS ORDERED TO HAVE A BLOOD TEST AND AN MRI. THE BLOOD TEST SHOWED HIGH LEVELS OF COBALT AND TITANIUM. THE MRI SHOWS AN ABNORMAL AMOUNT OF FLUID OUTSIDE THE JOINT AND DETERIORATION AROUND THE SOCKET. SHE IS SCHEDULED TO HAVE THE BALL AND SOCKET REPLACED WITH A PLASTIC LINED ONE ON (B)(6) 2012. THE METAL ON METAL JOINT NEVER WORKED AND HAS RESTRICTED HER MOVEMENT AND CAUSED HER PAIN SINCE IT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-METRIC LATZ 9X125 HIP REPLACEMENT KWA BIOMED X11-180309 260220
    2 M2A MAGNUM PF CUP 54 HIP REPLACEMENT KWA BIOMED US15854

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other