BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COMP LOCKING SCREW

    MDR report key: 3671129 · Received March 10, 2014

    Report

    Report Number
    0001825034-2014-01525
    Event Type
    Injury
    Date Received
    March 10, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 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
    SD, 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 DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 10 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - 180501; LOT NUMBER - 445930; EXPIRATION DATE - JAN 31, 2023; MANUFACTURE DATE ¿ JAN 15, 2013. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - 180503; LOT NUMBER - 013390; EXPIRATION DATE - NOV 30, 2022; MANUFACTURE DATE ¿ NOV 27, 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO THE GLENOSPHERE PULLING AWAY FROM THE GLENOID AND FRACTURING ONE OF THE LOCKING SCREWS AFTER A PATIENT FALL. THE FRACTURED SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143142 UNK COMP LOCKING SCREW PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention