BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 6124674 · Received November 23, 2016

    Report

    Report Number
    0001825034-2016-04832
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    August 25, 2015
    Report Date
    June 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS ABLE TO BE CONFIRMED UPON REVIEW OF MEDICAL RECORDS RECEIVED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT THERAPY DATE: (B)(6) 2015. CONCOMITANT MEDICAL PRODUCT -BIOMET M2A FEMORAL STEM CATALOG #: X181314 LOT # 306760, BIOMET M2A ACETABULAR CUP CATALOG#: US157856 LOT#: 914110, BIOMET M2A TAPER ADAPTER CATALOG #: 139256 LOT#: 382910

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN OPERATIVE REPORT RECEIVED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO METALLOSIS WITH INFLAMMATORY TISSUE AND FLUID COLLECTION. DURING THE PROCEDURE, THE FEMORAL HEAD WAS REMOVED AND REPLACED, AND A LINER WAS ALSO IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776718 M2A MAGNUM MODULAR HEAD HIP PROSTHESIS KWZ BIOMET ORTHOPEDICS N/A 049260

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R