BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2011718 · Received March 1, 2011

    Report

    Report Number
    1644408-2011-00106
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWL
    PMA / PMN Number
    K973614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE FIRST REVISION PRIMARY CUP FAILED DUE TO OSTEOLYSIS, THE SECOND REVISION ZIMMER CAGE FAILED AND THE PELVIS NEEDED TO BE PLATED. THE SAME SIZE HEAD AND SLEEVE WERE NEEDED, DJO STEM HAS NOT BEEN AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP UNIPOLAR FRACTURE SLEEVE KWL ENCORE MEDICAL, L.P. 53880860

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4), LOT A1000004