BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 1313220 · Received February 13, 2009

    Report

    Report Number
    1644408-2009-00069
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 27, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A SOFT TISSUE INJURY (RUPTURED QUADRACEPT) WHICH LED TO A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 53888616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention