BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 6274034 · Received January 24, 2017

    Report

    Report Number
    0001825034-2017-00251
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    November 3, 2016
    Report Date
    January 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE 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."

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: MODULAR TAPERLOC FEMORAL CATALOG #: 103200 LOT #:033940; M2A MAGNUM TAPER ADAPTER CATALOG#: 139254 LOT: 536670.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A MAGNUM (TM) CUP, CATALOG #: US157848, LOT #: 036560.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO UNSPECIFIED METAL ON METAL COMPLICATIONS. THE FEMORAL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56334 M2A MAGNUM MODULAR HEAD PROTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 532210

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R