BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VANGUARD TIBIAL BEARING

    MDR report key: 7262193 · Received February 9, 2018

    Report

    Report Number
    0001825034-2018-00520
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    January 8, 2018
    Report Date
    June 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: BIOMET MODULAR TIBIAL LOCKING BAR CAT#: 141205, LOT#: 432770. BIOMET CC TIBIAL TRAY CAT#: 141235, LOT#:311720. VANGUARD CR FEMORAL INTERLOCK CAT#: 183033, LOT#: 172960 . BIOMET ARCOM ALL POLY PATELLA CAT#: 11-150830, LOT#: 614550. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034 - 2018 - 00520, 0001825034 - 2018 - 00521

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00520-1; 0001825034-2018-00521-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FIRST STAGE REVISION SIX MONTHS AFTER LEFT KNEE REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105472 E1 VANGUARD TIBIAL BEARING PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 085670

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R