BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 TIB TRAY 75MM

    MDR report key: 4133671 · Received October 1, 2014

    Report

    Report Number
    0001825034-2014-07909
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    May 29, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "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 REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-07909 /-07921).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ASEPTIC LOOSENING OF COMPONENTS ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA ON (B)(6) 2014 DUE TO A STIFF KNEE FROM SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610859 BMT 360 TIB TRAY 75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 307940

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R