BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 42MM HEAD DIAMETER

    MDR report key: 6036162 · Received October 18, 2016

    Report

    Report Number
    0001825034-2016-04144
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    June 30, 2008
    Report Date
    September 19, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND CORRECTED INFORMATION. MEDICAL PRODUCT - BIOMET M2A MAGNUM CUP CATALOG#: US157848 LOT#: 833060, BIOMET M2A MAGNUM TAPER ADAPTER CATALOG#: 139252 LOT#: 181890, BIOMET TAPERLOC STEM CATALOG#: 11-103203 LOT#: 335640.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY THIRTEEN MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE ACETABULAR CUP AND FEMORAL HEAD WERE REMOVED AND REPLACED AND AN ACETABULAR LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687873 M2A MAGNUM MODULAR HEAD 42MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 108270

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R