BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL CONE

    MDR report key: 1883749 · Received October 2, 2008

    Report

    Report Number
    3005751028-2008-00022
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    January 8, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ZIMMER TMT
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULTS - DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION 2.5 WEEKS POST-OP. AS TREATMENT, A REVISION TIBIAL POLY COMPONENT WAS PERFORMED. THE HOSPITAL REPORTS THAT THE ZIMMER (B)(4) DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL CONE TM CONE MBH ZIMMER TMT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR