BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD ANT STBLZD BRG 10X71

    MDR report key: 8589394 · Received May 7, 2019

    Report

    Report Number
    0001825034-2019-02111
    Event Type
    Injury
    Date Received
    May 7, 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
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00957, 0001825034-2019-00958, 0001825034-2019-02111, AND 0001825034-2019-02112. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 67.5 CATALOG#: 183010 LOT#: J6042321, BIOMET CC CRUCIATE TRAY 71MM CATALOG#: 141233 LOT#: J3964040, SERIES A PAT THN 34 3 PEG CATALOG#: 184876 LOT#: 843490. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS EXPERIENCING PAIN AND POSSIBLE METAL ALLERGIES, BUT TESTING REVEALED NO METAL ALLERGIES. NO REVISION PROCEDURE HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378516 VNGD ANT STBLZD BRG 10X71 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 924210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other