BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TAPER INSERT-3

    MDR report key: 3062551 · Received April 17, 2013

    Report

    Report Number
    0001825034-2013-00993
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00992 / 00994 & 1825034-2013-01004).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH SPACERS AND PLATES. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164648 M2A-MAGNUM 42-50MM TAPER INSERT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 010070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R