BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 1912765 · Received November 2, 2010

    Report

    Report Number
    1644408-2010-00592
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWL
    PMA / PMN Number
    K973614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT DISLOCATED HIP, THE SURGEON REMOVED 46 UNIPOLAR HEAD AND SLEEVE. THE SURGEON REPLACED IT WITH SHELL, CONSTRAINED LINER AND 28MM HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP UNIPOLAR SLEEVE KWL ENCORE MEDICAL, L.P. 53950911

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention 411-00-146, LOT 281012