BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK KNEE

    MDR report key: 1289620 · Received January 13, 2009

    Report

    Report Number
    1644408-2009-00011
    Event Type
    Other
    Date Received
    January 13, 2009
    Date of Event
    December 19, 2008
    Report Date
    December 19, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION ON EXPLANTED PARTS RECEIVED. ENCORE WILL SUBMIT A FOLLOW-UP REPORT WHEN INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY - ENCORE NOTIFIED OF REVISION SURGERY. NO INFORMATION RECEIVED ON ORIGINAL PARTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention