BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1961707 · Received January 11, 2011

    Report

    Report Number
    1644408-2011-00022
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT COMPLAINED OF HIP PAIN. THE SURGEON SAW ACETABULAR LOOSENING RADIOGRAPHICALLY. THE ORIGINAL IMPLANT WAS IMPLANTED APPROXIMATELY TWELVE YEARS AGO. UPON SURGERY, THE CUP WAS DISCOVERED TO BE LOOSE WITH NO BONY IN GROWTH AND WAS REVISED. A NEW CUP AND LINER (STRYKER TITANIUM CUP SIZE 56 WITH X3 LINER) WAS INSERTED. A 40 MM +7 HEAD WAS INSERTED ONTO THE NEXT OF THE EXISTING REVELATION STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN JDI ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention