BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA 360 O/S TIB TRAY COCR 63

    MDR report key: 5694645 · Received June 2, 2016

    Report

    Report Number
    0001825034-2016-01901
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    September 21, 2015
    Report Date
    April 20, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K093293.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO TIBIAL TRAY LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348890 VG DA 360 O/S TIB TRAY COCR 63 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2420497

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R