BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 28MM HEAD DIAMETER

    MDR report key: 1980992 · Received February 8, 2011

    Report

    Report Number
    1825034-2011-00086
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 4, 2010
    Report Date
    January 12, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: UNDER ADVERSE EFFECTS, NUMBER SEVEN STATES, "UNDESIRABLE SHORTENING OF LIMB." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6), 2004. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2010, DUE TO SCREW FRACTURE, LOOSENING OF THE CUSTOM TRI-FLANGE COMPONENT, AND A LEG LENGTH DISCREPANCY. THE FEMORAL STEM AND CENTRALIZER COMPONENTS REMAIN IMPLANTED. THE MODULAR HEAD AND ALL ACETABULAR COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD COMPONENT 28MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 376470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R