BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ54MM

    MDR report key: 2580387 · Received May 18, 2012

    Report

    Report Number
    0001825034-2012-00636
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    April 16, 2012
    Report Date
    April 20, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00635 / 00638).

    Additional Manufacturer Narrative · 1

    UPON ARRIVAL, THE MODULAR HEAD, TAPER ADAPTER, AND FEMORAL STEM WERE STILL ASSEMBLED AND NO ATTEMPT WAS MADE TO SEPARATE THESE COMPONENTS. THE BEARING SURFACE OF THE MODULAR HEAD SHOWS FINE SCRATCHES AND METALLIC TRANSFER MARKS, TOGETHER WITH SOME DEEPER SCRATCHES OR INDENTATIONS IN PARALLEL BANDS. THESE DEEPER SCRATCHES OR INDENTATIONS ARE POSSIBLE INDICATIONS OF EDGE CONTACT WITH THE RIM OF THE CUP, POSSIBLY FROM SUBLUXATION OR DISLOCATION OF THE HEAD. THERE WAS NO EVIDENCE OF CHANGES IN SURFACE CONTOUR AT THE EDGES OF THE CONTACT AREA, FROM WHICH IT IS INFERRED THAT WEAR RATES WERE NOT EXCESSIVE. THE COMPONENTS APPEARED TO SHOW EVIDENCE OF NECK IMPINGEMENT AND SUBLUXATION OF THE JOINT. THESE EVENTS MAY HAVE BEEN CAUSAL OR CONTRIBUTORY FACTORS FOR THE HEAD BECOMING STUCK ON THE STEM TAPER. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00635-1 / 00638-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012, DUE TO LOOSENING. THE SURGEON REPORTEDLY COULD NOT DISENGAGE THE TAPER FROM THE STEM. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MOD HEAD SZ54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 154490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R