BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX M2A MAGNUM MODULAR HEAD 40MM HEAD DIAMETER PLUS 3MM NECK

    MDR report key: 6045160 · Received October 20, 2016

    Report

    Report Number
    0001825034-2016-04218
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04218 / 04219).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT IS SCHEDULED FOR A RIGHT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION BUT DID NOT INDICATE WHY A REVISION PROCEDURE WAS NECESSARY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF铠COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695471 SELEX M2A MAGNUM MODULAR HEAD 40MM HEAD DIAMETER PLUS 3MM NECK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 341800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R