BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM TAPER INSERT

    MDR report key: 6397021 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-00663
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    July 24, 2015
    Report Date
    February 14, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION TO THE CAUSE OF THE EVENT. ASSOCIATE PRODUCTS- M2A-MAGNUM MODULAR HEAD / PN 157444/ LN 182030, INTEGRA/X POROUS RED PROX / PN X12-171308/ LN 279310, M2A-MAGNUM PF CUP / PN US157850/ LN 395790 THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. 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
    178898 M2A-MAGNUM TAPER INSERT HIP PROSTHESIS KWA BIOMET ORTHOPEDICS N/A 985980

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R SEE H10 NARRATIVE