BEUDAMED
    FDA Adverse Event Other Summary report: N

    METAFIX HIP STEM

    MDR report key: 3772771 · Received March 4, 2014

    Report

    Report Number
    9614209-2014-00009
    Event Type
    Other
    Date Received
    March 4, 2014
    Date of Event
    February 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT (B)(4). THE DEVICE MFG RECORDS CONFIRM THAT ALL MATERIAL AND DIMENSIONAL SPECIFICATIONS WERE MET. THE OPERATIVE REPORT AND POST OPERATIVE X-RAYS HAVE BEEN SUPPLIED AND WILL BE REVIEWED.

    Description of Event or Problem · 1

    A METAFIX BROACH WAS IMPACTED INTO THE BONE; SUBSEQUENTLY IT BECAME STUCK IN THE FEMUR. THE BROACH COULD NOT BE EXTRACTED PROXIMALLY DURING SURGERY, THEREFORE, A LATERAL APPROACH WAS MADE. WHILST ATTEMPTING TO REMOVE THE BROACH, THE FEMUR WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130509 METAFIX HIP STEM UNCEMENTED HIP PROSTHESIS LZO CORIN LTD 340.435R 206943

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization