BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL TRAY

    MDR report key: 13995156 · Received April 4, 2022

    Report

    Report Number
    0001825034-2022-00790
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    December 21, 2021
    Report Date
    April 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD CR TIB BRG 10X71/75: CATALOG #: 183440; LOT #: 074310. BIOMET TIBIAL LOCKING BAR: CATALOG #: 141205; LOT #: 602670. VNGD CR TIB BRG 10X71/75: CATALOG #: 183440; LOT #: 229640. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES PROVIDED. DEVICE WAS NOT RETURNED. VISUAL EXAMINATION OF THE PROVIDED PHOTO CONFIRMS THE HOOK OF THE LOCKING BAR HAS FRACTURED OFF. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. THIS EVENT WAS INITIALLY REPORTED UNDER 0001825034-2021-03462 AND 0001825034-2022-00085.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO FRACTURED LOCKING BAR. PRIOR TO SURGERY X-RAY SHOWED DISLODGED LOCKING BAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94073 UNKNOWN TIBIAL TRAY PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H