BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINEAR HIP

    MDR report key: 2111184 · Received May 26, 2011

    Report

    Report Number
    1644408-2011-00299
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN WE OPENED THE SIZE 12 LATERAL LINER STEM, THE BAG HAD BEEN COMPROMISED BY THE POROUS MATERIAL. THE OUTER BAG WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR HIP LATERAL OFFSET STEM LPH ENCORE MEDICAL, L.P. 53784221

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 497-38-000, LOT 54050919| 411-00-350, LOT A1000000| 430-03-056, LOT A1000002| 49938-009, LOT 53951751