BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD -3MM NK

    MDR report key: 3233607 · Received July 18, 2013

    Report

    Report Number
    0001825034-2013-02744
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    February 6, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02743 / 02744).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE M2A-38 STUDY UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2013, DUE TO POTENTIAL INFECTION OR METALLOSIS. REVIEW OF MEDICAL RECORDS CONFIRMED METALLOSIS. LAB RESULTS FOUND NO EVIDENCE OF INFECTION. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. THE STEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335880 M2A 38MM MODULAR HEAD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 591810

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R