BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SEGMENTAL ANCHOR PLUG 14MM

    MDR report key: 2120368 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00490
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." EVALUATION OF THE RETURNED COMPONENT FOUND THE SURFACE ARTIFACTS SUGGEST THE FRACTURE OCCURRED IN HIGH STRESS FATIGUE. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6), 2005. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 TO REMOVE AND REPLACE A FRACTURED ANCHOR PLUG. DURING THE PROCEDURE, THE SURGEON INTENDED TO REPLACE THE 5CM TAPER ADAPTER AND THE 3CM SEGMENT; HOWEVER, THE APPROPRIATE COMPONENTS TO COMPLETE THE CONSTRUCT WERE NOT AVAILABLE TO COMPLETE THE PROCEDURE. THE PATIENT WAS BROUGHT BACK TO THE O.R. ON (B)(6), 2011 TO IMPLANT THE COMPONENTS NEEDED TO COMPLETE THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESS SEGMENTAL ANCHOR PLUG 14MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 582000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R