BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLC MCR HIGH OFFSET 13MM

    MDR report key: 7545653 · Received May 25, 2018

    Report

    Report Number
    0001825034-2018-03655
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 26, 2018
    Report Date
    December 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 51-104150, TPRLC 133 T1 PPS HO 15X150MM, LOT # 6241784. REPORTED EVENT IS CONSIDERED CONFIRMED AS VISUAL EXAMINATION SHOWED THE DEVICE HAD DEBRIS IN THE PACKAGING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE PRODUCTS WHEN LEAVING ZIMMER BIOMET WERE NON-CONFORMING. ROOT CAUSE WAS DUE TO MANUFACTURING DEFICIENCY AS THE REPORTED EVENT OCCURRED DURING THE MANUFACTURING PROCESS. 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). (B)(6). 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 DEBRIS WAS FOUND IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388564 TLC MCR HIGH OFFSET 13MM PROSTHESIS KNEE KWA ZIMMER BIOMET, INC. N/A 6246511

    Patients

    Seq Age Sex Outcome Treatment
    1