BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2034739 · Received March 24, 2011

    Report

    Report Number
    1644408-2011-00151
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE POLY WAS WORN OUT AFTER 17 YEARS. THE ORIGINAL SURGEON HAS SINCE RETIRED AND NO RECORDS CAN BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN N/A ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention