BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR-LIPPED TIBIAL BEARING 10MM X 79/83MM

    MDR report key: 6357309 · Received February 24, 2017

    Report

    Report Number
    0001825034-2017-00898
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    January 24, 2017
    Report Date
    September 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00897).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-LT 75 P/N 183034 L/N 834540, BIOMET CC CRUCIATE TRAY 79 MM P/N 141235 L/N 778010. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED TO DUE TO A FRACTURED PATELLA COMPONENT AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139604 VANGUARD CR-LIPPED TIBIAL BEARING 10MM X 79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 547300

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 11150828 BMET ARCOM AP PAT W/WIRE, LOT 779780