BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SEGMENTAL ANCHOR PLUG 12MM

    MDR report key: 2132908 · Received June 17, 2011

    Report

    Report Number
    1825034-2011-00512
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND EVIDENCE THAT SUGGESTS A FATIGUE FRACTURE. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. INITIAL REPORTER - REVISING SURGEON IS UNKNOWN. 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: UNDER POSSIBLE ADVERSE EFFECTS, (B)(4) STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE SYSTEM PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON UNKNOWN DATE, DUE TO THE ANCHOR PLUG FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESS SEGMENTAL ANCHOR PLUG 12MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 898850

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R