BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS OPEN INTL FEM RT 70

    MDR report key: 8912834 · Received August 20, 2019

    Report

    Report Number
    0001825034-2019-03719
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    August 31, 2018
    Report Date
    August 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS ORIGINALLY SENT UNDER MFR# 0001822565-2018-06501 AFTER RECEIVING ADDITIONAL INFORMATION, THIS EVENT WILL NOW BE SENT UNDER MFR# 0001825034-2019-03719. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03712. CONCOMITANT MEDICAL PRODUCTS - VNGD PS TIB BRG 10X79/83MM, CATALOG#: 183660, LOT#: 081220; POLISHED FINNED TIB TRAY 83MM, CATALOG#: 141256, LOT#: 2018010134. REPORT SOURCE- (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT DEBRIDEMENT TO TREAT DELAYED WOUND HEALING TWO (2) MONTHS POST INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706354 VNGD PS OPEN INTL FEM RT 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6183609

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R