BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 SM CRUCIATE AUG TRL

    MDR report key: 4861888 · Received June 23, 2015

    Report

    Report Number
    0001825034-2015-02672
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 27, 2015
    Report Date
    July 20, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THAT THE ROOT CAUSE OF THE EVENT WAS DUE TO EXCESSIVE FORCE DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE OF UNKNOWN KNEE ON (B)(6) 2015 DUE TO UNKNOWN REASONS. DURING THE PROCEDURE TO IMPLANT A BIOMET KNEE, IT WAS NOTED THAT A PEG WAS MISSING FROM THE AUGMENT PUNCH. THIS MADE IT DIFFICULT TO INSERT THE TIBIAL COMPONENT AND THE IMPLANTS WOULD NOT SEAT PROPERLY, CAUSING THEM TO LIFT AND ROTATE. IT WAS DECIDED TO REMOVE ALL COMPONENTS AND THE SURGEON RE-IMPLANTED. A DELAY GREATER THAN THIRTY MINUTES OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406612 BMT 360 SM CRUCIATE AUG TRL PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 823400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R