BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 1960274 · Received January 7, 2011

    Report

    Report Number
    1644408-2011-00003
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K973614
    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 HAD A HEMI-ARTHROPLASTY SURGERY IN 2001. THE PATIENT EXPERIENCED PAIN IN THE HIP. THE SURGEON CONVERTED THE UNIPOLAR HIP TO A TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP UNIPOLAR FRACTURE HEAD LPH ENCORE MEDICAL, L.P. 463521

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 411-00-350, LOT 694381