BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 2489018 · Received March 13, 2012

    Report

    Report Number
    0001825034-2012-00241
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    December 13, 2011
    Report Date
    July 29, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS ... PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID." "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION MAY LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." THIS IS MDR TWO OF THREE (1825034-2012-00240 THROUGH 00242) FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    USER FACILITY SENT MEDWATCH REPORT (B)(4) WHICH CORRELATES TO THE SAME EVENT. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00240-1 / 00242-1).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011. THE PATIENT ALLEGES REVISION WAS DUE TO METALLOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011. THE PATIENT ALLEGES REVISION WAS DUE TO METALLOSIS. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES REPORTS THE PATIENT WAS REVISED ON THE LEFT HIP DUE TO PAIN AND METALLOSIS. REVISION OP REPORT NOTES THE EXTERNAL ROTATORS WERE ELEVATED FROM THE POSTERIOR ASPECT OF THE TROCHANTER AND THE PRESENCE OF SLIGHTLY CLOUDY, BROWNISH FLUID AND BROWNISH AND GRAYISH BROWN TISSUE. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. THE CUP REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM 42-50MM TPR INSRT-3 M2A MAGNUM TAPER INSERT KWA BIOMET ORTHOPEDICS N/A 817370

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R