BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD ARTICULAR SURFACE

    MDR report key: 7455653 · Received April 24, 2018

    Report

    Report Number
    0001825034-2018-02977
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    April 5, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: VNGD SSK 360 L FEM; P/N: 185284, L/N: 3603059, BMT SMOOTH KNEE STEM; P/N: 145026, L/N: 470050, VG DA 360 O/S TIB TRAY; P/N: 161431, L/N: 3535584, BMT SMOOTH KNEE STEM; P/N: 145024, L/N: 316550. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION OF THE POLYETHYLENE BEARING. ALL PRODUCTS WERE REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISLOCATION IN LEFT KNEE POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT WILL BE CONSIDERED FOR REVISION SURGERY ON AN UNKNOWN DATE. NO REVISION PROCEDURE HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298729 UNKNOWN VANGUARD ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R