BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBT TIBIAL IMPACTOR

    MDR report key: 1061465 · Received June 13, 2008

    Report

    Report Number
    1818910-2008-02149
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING IMPLANTATION, TWO TIBIAL IMPACTORS CAUSING A DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT TIBIAL IMPACTOR 87LXH HWA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA