BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER MINUS 3 NECK

    MDR report key: 6038096 · Received October 18, 2016

    Report

    Report Number
    0001825034-2016-04145
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    April 13, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    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 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 RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A ACETABULAR CUP CATALOG#: RD118848 LOT#: 947980; BIOMET FEMORAL STEM CATALOG#: X180310 LOT#: 662761.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE APPROXIMATELY THIRTEEN YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. DURING THE PROCEDURE, THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. A LINER AND TAPER ADAPTER WERE ALSO IMPLANTED. 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
    688988 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER MINUS 3 NECK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 000350

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R