BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD BEARING

    MDR report key: 8006728 · Received October 25, 2018

    Report

    Report Number
    0001825034-2018-09934
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    March 16, 2018
    Report Date
    February 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION, IT WAS DETERMINED NOT TO BE REPORTABLE AS THERE WAS NO ZIMMER BIOMET DEVICES INVOLVED IN THE ALLEGED EVENT.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION, IT WAS DETERMINED NOT TO BE REPORTABLE AS THERE WAS NO ZIMMER BIOMET DEVICES INVOLVED IN THE ALLEGED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BORN 1950. IMPLANTED: (B)(6) 2016 MEDICAL PRODUCTS- VANGUARD FEMORAL COMPONENT, CATALOG # 183128, LOT # UNKNOWN, UNKNOWN VANGUARD TIBIAL COMPONENT, CATALOG # UNKNOWN, LOT # UNKNOWN. FOREIGN SOURCE- (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 LEFT KNEE ARTHROPLASTY TWO YEARS AGO. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PAIN AND INSTABILITY. THE PATIENT'S BEARING WAS REVISED DUE TO INSTABILITY. 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
    843800 UNKNOWN VANGUARD BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R