BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL AUG 75 X 15 MM LL/RM

    MDR report key: 3973819 · Received August 1, 2014

    Report

    Report Number
    3002806535-2014-00180
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED FOR EVALUATION. EVALUATION CONFIRMED THE SCREWS AND AUGMENT CONFORMED TO THE DRAWING SPECIFICATION FOR THE MANUFACTURING TIME PERIOD. THE VANGUARD TIBIAL TRAYS HAVE THE THREADS CAST INTO THEM WITH A 3.5MM DEPTH. AS A RESULT, WHEN THE AUGMENT IS ASSEMBLED TO THE TIBIAL TRAY, THE 6MM PROTRUSION OF THE SCREW TOUCHES THE BOTTOM OF THE THREADED HOLE IN THE TRAY BEFORE IT IS ABLE TO TIGHTEN THE TRAY ONTO THE AUGMENT. THE DRAWING INDICATED THE AUGMENTS WERE BEING MANUFACTURED WHILE A CHANGE WAS BEING IMPLEMENTED TO CHANGE THE COUNTER BORE HOLE DIMENSIONS.

    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. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    DURING AN INITIAL PROCEDURE ON (B)(6), 2014, IT WAS REPORTED IT WASN'T POSSIBLE TO FIX THE AUGMENT WITH THE TIBIA PLATEAU. THERE WAS A GAP BETWEEN THE AUGMENT AND THE TIBIA PLATEAU. THERE WAS A DELAY IN PROCEDURE OF 40 MINUTES DUE TO THE EVENT. TO COMPLETE THE PROCEDURE, THE SURGEON USED A SMALLER AUGMENT. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451190 BIOMET 360 TIBIAL AUG 75 X 15 MM LL/RM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 1514055

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R