BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SIZE 48MM

    MDR report key: 2506210 · Received March 27, 2012

    Report

    Report Number
    0001825034-2012-00333
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 10, 2012
    Report Date
    March 2, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, AS WELL AS THE PATIENT'S DATE OF BIRTH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER ONE STATES, "MATERIAL SENSITIVITY REACTIONS". NUMBER FOURTEEN STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN". THIS REPORT IS NUMBER 1 OF 3 FOLLOW-UP MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00331-1 / 00333-1).

    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. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00331 / 00333). THE USER FACILITY WAS NOTIFIED OF THE EVENT ON MARCH 27, 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A M2A HIP PROCEDURE ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012, FOR UNKNOWN REASON. THE ACETABULAR CUP, TAPER INSERT, AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A M2A HIP PROCEDURE ON (B)(6), 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2012, DUE TO TENDONITIS AND METAL SYNOVITIS. THE ACETABULAR CUP, TAPER INSERT, AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MODULAR HEAD SIZE 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 820930

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R