BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TAPER ADAPTER

    MDR report key: 1842651 · Received September 23, 2010

    Report

    Report Number
    1825034-2010-00387
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    April 29, 2008
    Report Date
    August 26, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. PATIENT EXPERIENCED DISASSOCIATION AND A PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN WHICH THE MODULAR HEAD WAS REMOVED, CLEANDED, AND THEN RE-IMPLANTED. SUBSEQUENTLY, THE PATIENT AGAIN EXPERIENCED DISASSOCIATION AND REVISION WAS PERFORMED ON (B)(6), 2009, IN WHICH THE MAGNUM MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM TAPER ADAPTER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 267200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R