BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIMIX

    MDR report key: 597564 · Received April 28, 2005

    Report

    Report Number
    1032347-2005-00006
    Event Type
    Other
    Date Received
    April 28, 2005
    Date of Event
    April 10, 2005
    Report Date
    April 28, 2005
    Manufacturer
    BIOMET MANUFACTURING CORP.
    Product Code
    GXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DOCTOR IMPLANTED 10 GRAMS OF MIMIX, SURGERY DATE AROUND 2005. 4 WEEKS POST INFLAMMATION DEVELOPED AND DIDN'T RESOLVE. REVISION SURGERY ABOUT 2 MONTHS LATER, REMOVED MIMIX. DOCTOR DIDN'T REPLACE REMOVED MIMIX WITH ANYTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIMIX BONE VOID FILLER GXP BIOMET MANUFACTURING CORP. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O