BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY TIBIAL BEARING 12MM X 71/75MM

    MDR report key: 15670551 · Received October 25, 2022

    Report

    Report Number
    0001825034-2022-02326
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    April 25, 2022
    Report Date
    October 25, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT DEVICES - BIOMET PRIMARY TIBIAL TRAY 75MM, CATALOG #: 141214, LOT #: 225390, MAXIM POROUS PRIMARY FEMORAL COMPONENT 70 LEFT, CATALOG #: 140073, LOT #: 915050, BIOMET FINNED PRIMARY STEM 40MM, CATALOG #: 141314, LOT #: 127190. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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 THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLA PAIN AND KNEE EFFUSION APPROXIMATELY SEVENTEEN (17) YEARS POST-OPERATIVELY. DURING THE PROCEDURE, THE PATELLA WAS RESURFACED AND THE TIBIAL BEARING WAS ALSO REPLACED WITH A LARGER BEARING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774965 MAXIM PRIMARY TIBIAL BEARING 12MM X 71/75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 146310

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H