BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 46 MM HEAD DIAMETER

    MDR report key: 6039394 · Received October 19, 2016

    Report

    Report Number
    0001825034-2016-04154
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    January 12, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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 OR DEVIATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO REPORT ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT PRODUCTS: M2A MAGNUM PF CUP 520D ITEM # US157852 LOT# 618790, MLRY-HD LAT POR FMRL - ITEM # 11-104210 LOT # 080690, M2A- MAGNUM 42-50 MM TPR - ITEM # 139252 LOT # 762680.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF INVOICE HISTORY SHOWS THE MODULAR HEAD WAS REMOVED AND REPLACED AND A HIP BEARING WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO ELEVATED METAL IONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF INVOICE HISTORY SHOWS THE MODULAR HEAD WAS REMOVED AND REPLACED AND A HIP BEARING WAS IMPLANTED. MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693516 M2A MODULAR HEAD COMPONENT 46 MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 458660

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R