BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL BASEPLATE

    MDR report key: 2666962 · Received July 18, 2012

    Report

    Report Number
    MW5026255
    Event Type
    Injury
    Date Received
    July 18, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 18, 2012
    Manufacturer
    BIOMET, INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOOSE, BROKEN BIOMET TIBIAL BASEPLATE AND INSERT FROM RIGHT TOTAL KNEE REPLACEMENT FROM PRIOR SURGERY IN 2004 AT A DIFFERENT FACILITY. PT REQUIRED RIGHT TOTAL KNEE REVISION ON (B)(6) 2012. REASON FOR USE: DJD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL BASEPLATE BIOMET TIBIAL BASEPLATE JWH BIOMET, INC 453150
    2 TIBIAL INSERT INSERT JWH BIOMET, INC 179850

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R