BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORMET METAL ON METAL HIP RESURFACING

    MDR report key: 1582893 · Received January 15, 2010

    Report

    Report Number
    9614209-2009-00007
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    April 30, 2009
    Report Date
    May 1, 2009
    Manufacturer
    CORIN LTD
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS PART OF THE CORMET IDE STUDY. TROCHANTERIC BURSITIS OF THE RIGHT HIP WAS NOTED AND REPORTED IN THE IDE ON (B)(4) 2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS REVISED TO A TOTAL HIP FOR ACETABULAR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMET METAL ON METAL HIP RESURFACING CORMET FEMORAL HEAD COMPONENT NXT CORIN LTD FZSZ

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention CORMET CUP, 179.048 LOT CODE FEWL