BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY 2.5MM ADAPTOR

    MDR report key: 2547414 · Received April 25, 2012

    Report

    Report Number
    0001825034-2012-00527
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY". THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00526 / 00527).

    Additional Manufacturer Narrative · 1

    REVIEW OF EXPLANTED DEVICE FOUND NUMEROUS GOUGES AND DENTS. WITHOUT THE PROPER ASSEMBLY OF THE LOCKING SCREW THE TIBIAL TRAY WOULD VERY LIKELY LOOSEN. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00526-1 / 00527-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO LOOSENING OF THE TIBIA BETWEEN THE TIBIAL PLATE AND THE OFFSET TIBIAL TRAY ADAPTER. THE LOCKING SCREW THAT CONNECTS THE TIBIAL PLATE AND TIBIAL TRAY ADAPTER WAS NOT ASSEMBLED DURING THE INITIAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET OFFSET TIBIAL TRAY 2.5MM ADAPTOR PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 632400

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R