BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 8MM MINI

    MDR report key: 5108711 · Received September 28, 2015

    Report

    Report Number
    0001825034-2015-04104
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    BIOMET SET
    Product Code
    KWS
    PMA / PMN Number
    PK992899
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND/OR EXCESSIVE ACTIVITY.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO RADIOGRAPHIC LOOSENING OF THE STEM. PATIENT'S PREVIOUS SHOULDER FRACTURE MAY HAVE CONTRIBUTED TO THE LOOSENING. THE PRIMARY STEM, TRAY, AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638447 COMP PRIMARY STEM 8MM MINI PROSTHESIS, SHOULDER KWS BIOMET SET N/A 143860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R