BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 67.5

    MDR report key: 8407937 · Received March 11, 2019

    Report

    Report Number
    0001825034-2019-00957
    Event Type
    Injury
    Date Received
    March 11, 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

    UDI: (B)(4). INVESTIGATION IS UNDER PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00958, 0001825034-2019-02111, AND 0001825034-2019-02112.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : BIOMET CC CRUCIATE TRAY 71MM CATALOG#: 141233 LOT#: J3964040, VNGD ANT STBLZD BRG 10X71 CATALOG#: 189060 LOT: 924210, SERIES A PAT THN 34 3 PEG CATALOG#: 184876 LOT#: 843490.

    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

    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.

    Description of Event or Problem · 0

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

    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 AND 0001825034-2019-00958. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VANGUARD TIBIAL TRAY, CATALOG#: NI, LOT#: NI; UNKNOWN VANGUARD TIBIAL INSERT, CATALOG#: NI, LOT#: NI; UNKNOWN VANGUARD PATELLA, CATALOG#: NI, LOT#: NI. 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. NO REVISION PROCEDURE HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200475 VANGUARD CR ILOK FEM-RT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6042321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other