BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY LIPPED TIBIAL BEARING 12MM X 79/83MM

    MDR report key: 7995711 · Received October 23, 2018

    Report

    Report Number
    0001825034-2018-09756
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    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). CONCOMITANT DEVICES - MAXIM POROUS FEMORAL COMPONENT 75MM LEFT, CATALOG #: 140074, LOT #: 522810. BIOMET CC CRUCIATE TIBIAL TRAY 79MM, CATALOG #: 141235, LOT #: 937180. BIOMET ARCOM PATELLA 37MM, CATALOG #: 11-150830, LOT #: 477980. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW; HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. 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 IS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE POLYETHYLENE BEARING DUE TO UNKNOWN REASONS APPROXIMATELY SIXTEEN (16) YEARS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834973 MAXIM PRIMARY LIPPED TIBIAL BEARING 12MM X 79/83MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 413480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R