BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD EXPANSION CLIP MARK III

    MDR report key: 2080281 · Received May 6, 2011

    Report

    Report Number
    1825034-2011-00340
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, AND/OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT WAS INCONCLUSIVE. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROUTINE EXPANSION PROCEDURE TO PLACE AN EXPANSION SEGMENT ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN WHILE SHOOTING BASKETS AND WAS REVISED ON (B)(6) 2011. THE EXPANSION SEGMENT HAD BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD EXPANSION CLIP MARK III PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 684290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R