BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 14X71/75MM

    MDR report key: 5858225 · Received August 9, 2016

    Report

    Report Number
    0001825034-2016-03022
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-03021 & 03022). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS - FEMUR - CATALOGUE: 183108 LOT 518530, TIBIAL TRAY - CATALOGUE: 141213 LOT 621450, PATELLA - CATALOGUE: 11-150842 LOT 468530, STEM - CATALOGUE: 141318 LOT 628250, LOCKING BAR - CATALOGUE: 141205 LOT 597160, BEARING - CATALOGUE: 183644 LOT 706470. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES.

    Description of Event or Problem · 1

    PATIENT WAS REVISED APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509104 VNGD PS TIB BRG 14X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 706470

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R