BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD KNEE SYSTEM CR LIPPED TIBIAL BEARING DCM ARCOM

    MDR report key: 8331891 · Received February 12, 2019

    Report

    Report Number
    0001825034-2019-00502
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    January 17, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES OR MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- VANGUARD CR INTERLOK FEMORAL COMPONENT, CATALOG # 183008, LOT # J3814910; VANGUARD POLISHED TIBIAL TRAY, CATALOG # 141242, LOT # 2016042162. REPORT SOURCE: FOREIGN - (B)(6). OUR INVESTIGATION IS ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. LOCATION OF DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE APPROXIMATELY TWO YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSE MEDIAL LIGAMENT. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED ALONG WITH AUGMENTATION TO CORRECT THE REPORTED EVENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126885 VANGUARD KNEE SYSTEM CR LIPPED TIBIAL BEARING DCM ARCOM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 193050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R