BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 3223494 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02669
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 13, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EVALUATION OF THE EXPLANTED DEVICE FOUND THE TORSIONAL FORCE THAT WAS APPLIED TO THE TAPER CANNOT BE DETERMINED.

    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 WARNINGS, 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."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, A REVISION WAS PERFORMED (B)(6) 2013 DUE TO THE TAPER FRACTURED OFF OF HUMERAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323158 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 697180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R