BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN BIOMET VANGUARD STEM

    MDR report key: 6641169 · Received June 14, 2017

    Report

    Report Number
    0001825034-2017-04031
    Event Type
    Death
    Date Received
    June 14, 2017
    Report Date
    June 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6). CRAWFORD, DAVID ET AL. "LOW RATES OF ASEPTIC TIBIAL LOOSENING IN OBESE PATIENTS WITH USE OF HIGH VISCOSITY CEMENT AND STANDARD TIBIAL TRAY: 2-YEAR MINIMUM FOLLOW-UP" (2017). INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY DAVID CRAWFORD, KEITH BEREND, DENIS NAM, ROBERT BARRACK, JOANNE ADAMS, ADOLPH LOMBARDI. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 94 PATIENTS (118 KNEES) WERE EXCLUDED FROM THE STUDY DUE TO DEATH. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422801 UNKNOWN BIOMET VANGUARD STEM POSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death