BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMET REGENX PRI TIB TRAY 75MM

    MDR report key: 3931549 · Received July 14, 2014

    Report

    Report Number
    0001825034-2014-06128
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 ASSOCIATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES: "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. UPON RECEIPT, THE TIBIAL TRAY WAS FRACTURED INTO TWO PIECES AND SHOWED SEVERAL SIGNS OF BIOLOGIC FIXATION. THE PART MOST LIKELY FAILED FROM BIOMECHANICAL OVERLOAD DUE TO THE PATIENT¿S WEIGHT.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2013. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT WAS REVISED ON (B)(6), 2014 DUE TO PATIENT ALLEGATIONS OF A FRACTURED TIBIAL TRAY. THE TIBIAL TRAY, TIBIAL BEARING AND FEMORAL COMPONENT WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409413 BMET REGENX PRI TIB TRAY 75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 086710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R