BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 1943108 · Received December 30, 2010

    Report

    Report Number
    1825034-2010-00693
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    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: "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 REPORT FILED DECEMBER 30, 2010.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM HOSPITAL RESEARCH FACILITY OF A REVISION THAT TOOK PLACE WHERE THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED. THE SURGEON REPORTED TO THE RESEARCH FACILITY THAT HE NOTED GREYISH FLUID, A SOFT TISSUE MASS AND METALLOSIS DURING THE REVISION PROCEDURE. HE ALSO NOTED THAT HE HAD DIFFICULTY DISENGAGING THE TAPER ADAPTER FROM THE FEMORAL STEM AND THAT THE CUP WAS STEEP. FOLLOW UP WAS CONDUCTED TO OBTAIN PRODUCT IDENTIFICATION FROM THE RESEARCH FACILITY. A REVIEW OF INVOICE HISTORY FOR THE PART NUMBERS PROVIDED CONFIRMED THE DATE OF THE INITIAL TOTAL HIP ARTHROPLASTY WAS (B)(6) 2008. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 FOR AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 035190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R