BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 6221669 · Received January 4, 2017

    Report

    Report Number
    0001825034-2017-00029
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    October 21, 2016
    Report Date
    June 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VAN PS OPEN INTL FEM-LT 62.5 CATALOG #183126, LOT #J3632652; POLISHED FINNED TIB TRAY 75 MM, CATALOG #141254, LOT #2015110911; BIOMET BONE CEMENT 1X40G, CATALOG #3035890011 LOT#A511AL1502. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF OPERATIVE NOTES PROVIDED. REVIEW OF THE INITIAL AND REVISION OPERATIVE NOTES INDICATED THAT THERE WERE NO COMPLICATIONS NOTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THAT DURING A PROCEDURE THE LOCKING BAR WOULD NOT FIT WELL IN THE BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5218 VANGUARD PS TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 464320

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention