BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR INTLK FEMORAL 55MM RT

    MDR report key: 10244741 · Received July 8, 2020

    Report

    Report Number
    0001825034-2020-02668
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 7, 2020
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 183422 - VNGD CR TIB BRG - 358120. 141221 - BIOMET CC I-BEAM TRAY - 048610. NO DEVICES OR PHOTOGRAPHS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02667.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT RIGHT KNEE REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO INSTABILITY. THE POLY BEARING WAS REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT'S PATELLA WAS RESURFACED AND A PATELLA WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708644 VNGD CR INTLK FEMORAL 55MM RT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 441110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R