BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIDFIX FEMORAL ST CROSS PIN KIT

    MDR report key: 2419194 · Received January 11, 2012

    Report

    Report Number
    MW5023811
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD ACL RECONSTRUCTION (B)(6) 2011. ON VISIT TO SURGEON IN (B)(6) 2011, PT COMPLAINING OF PAIN AND WEAKNESS. MRI DONE (B)(6) 2011 WHICH SHOWED A DISPLACED FRAGMENT OF THE FEMORAL FIXATION PIN IN THE MEDIAL JOINT SPACE OF THE KNEE. PT UNDERWENT KNEE ARTHROSCOPY WITH REMOVAL OF LOOSE FOREIGN BODY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX FEMORAL ST CROSS PIN KIT RIGIDFIX FEMORAL ST CROSS PIN KIT MBI DEPUY MITEK, INC. 3473248

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Disability