BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL SCR 6.5X30MM ST

    MDR report key: 4180137 · Received October 17, 2014

    Report

    Report Number
    0001825034-2014-08136
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 DEVIATION OR ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY" AND NUMBER 5 STATES ¿IF GLENOID COMPONENT IS NOT SECURELY FIXED, MICROMOTION CAN LEAD TO PERIPHERAL SCREW FAILURE.¿ THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014- 08136 / 08137/ 08138 / 08139).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISEASE PROGRESSION AND THE PATIENT WAS CONVERTED TO A REVERSE SHOULDER. ON (B)(6) 2014 THE GLENOID COMPONENTS, HUMERAL TRAY AND BEARING WERE REVISED DUE TO LOOSENING AND FRACTURED SUPERIOR AND CENTRAL SCREWS. THE SCREWS WERE REPLACED WITH EAS (EASY OUT) HEAD SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662550 COMP RVS CNTRL SCR 6.5X30MM ST SCREWS - PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 213710

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R