BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT REVISION CEM TIB TRAY SZ 4

    MDR report key: 721142 · Received May 26, 2006

    Report

    Report Number
    1818910-2006-01471
    Event Type
    Injury
    Date Received
    May 26, 2006
    Date of Event
    May 2, 2006
    Report Date
    May 2, 2006
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REVISED DUE TO LOOSENING, HOWEVER, INOPERATIVELY DID NOT FIND TIBIA GROSSLY LOOSE, IT TOOK OVER TWO HOURS TO REMOVE. DO1 2004 DOR 05/02/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT REVISION CEM TIB TRAY SZ 4 TOTAL KNEE REPLACEMENT HSH DEPUY ORTHOPAEDICS, INC. NA YP5B5A000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention