BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 8MM MINI

    MDR report key: 2924085 · Received January 22, 2013

    Report

    Report Number
    0001825034-2013-00125
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    May 16, 2011
    Report Date
    December 27, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00125 / 00127).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT IN (B)(4) STUDY UNDERWENT RIGHT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT FELL CAUSING ANTERIOR SUBLUXATION. NO REVISION IS PLANNED DUE TO PATIENT'S AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31032 COMP PRIMARY STEM 8MM MINI PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 681920

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| S