BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINEAR HIP

    MDR report key: 2011715 · Received March 1, 2011

    Report

    Report Number
    1644408-2011-00103
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - REVISION OF FEMORAL STEM FOR FEMORAL PERFORATION; NO INSTRUMENT MALFUNCTION TO REPORT; THE PATIENT WAS IN NO IMMINENT DANGER, NOT AN IMPLANT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR HIP LATERAL OFFSET STEM LPH ENCORE MEDICAL, L.P. 11631001

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention (B)(4), LOT 866B1004