BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIGHLY CROSS LINKED POLYETHYLENE LINER

    MDR report key: 1220564 · Received October 31, 2008

    Report

    Report Number
    1644408-2008-00383
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ACETABULAR CUP UNSTABLE. NEEDED TO REPOSITION AND INCREASE SIZE OF CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGHLY CROSS LINKED POLYETHYLENE LINER ACETABULAR LINER, HXL NON-HOODED KWB ENCORE MEDICAL, L.P. 53919665

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 497-36-000/(B) (4)| 411-00-350/(B) (4)| 430-30-054/(B) (4)