BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP NON-LCKNG SCREW

    MDR report key: 3441078 · Received October 31, 2013

    Report

    Report Number
    0001825034-2013-05060
    Event Type
    Injury
    Date Received
    October 31, 2013
    Date of Event
    December 30, 2010
    Report Date
    October 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 - 180510, LOT NUMBER - 436590, EXPIRATION DATE - MAR 31, 2019, MANUFACTURE DATE ¿ MAR 5, 2009; CATEGORY NUMBER - 180511, LOT NUMBER - 436620, EXPIRATION DATE - MAR 31, 2019, MANUFACTURE DATE ¿ MAR 18, 2009; CATEGORY NUMBER - 180511, LOT NUMBER - 402360, EXPIRATION DATE - MAY 31, 2019, MANUFACTURE DATE ¿ MAY 22, 2009; CATEGORY NUMBER - 180510, LOT NUMBER - 448060, EXPIRATION DATE - JUN 30, 2019, MANUFACTURE DATE ¿ JUN 17, 2009. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-05060 / 05062).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010 DUE TO TWO FRACTURED PERIPHERAL SCREWS. ALL COMPONENTS WERE REMOVED AND REPLACED. PATIENT WAS REVISED TO A HEMIARTHROPLASTY ON (B)(6) 2013 DUE TO A FRACTURED PERIPHERAL SCREW AND CENTRAL SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560357 COMP NON-LCKNG SCREW PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R