BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 2580171 · Received May 18, 2012

    Report

    Report Number
    0001825034-2012-00630
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 19, 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

    THE ARTICULAR SURFACE OF THE CUP SHOWED EVIDENCE OF SCRATCHING AND STAINING OVER THE WHOLE ARTICULAR SURFACE. THE DISCOLORATION WAS POSSIBLY CAUSED BY STEAM AUTOCLAVE STERILIZATION OF THE COMPONENT. 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. WORN INDENTATIONS OR DEFORMATION MARKS WERE VISIBLE AT THE RIM OF THE BEARING SURFACE. IT IS POSSIBLE THAT THIS WEAR OR DEFORMATION MIGHT HAVE OCCURRED DUE TO SUBLUXATION OF THE HEAD OR STEM IMPINGEMENT. ROOT CAUSE FOR THE MODULAR HEAD BEING STUCK TO THE STEM TAPER COULD NOT BE DETERMINED. THIS FOLLOW-UP REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00630-1 / 00633-1).

    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 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00630 / 00633).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO MIGRATION OF THE ACETABULAR CUP. THE MODULAR HEAD COULD NOT BE DISENGAGED FROM THE STEM AND A MIDAS-REX WAS USED TO CUT 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 PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 057410

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R