BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 10MM MINI

    MDR report key: 5887358 · Received August 18, 2016

    Report

    Report Number
    0001825034-2016-03161
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    August 6, 2015
    Report Date
    July 19, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY EXPERIENCED HUMERAL RADIOLUCENCY PROGRESSION FROM 1 MM TO 2 MM IN ZONE 8 APPROXIMATELY ONE YEAR POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538064 COMP PRIMARY STEM 10MM MINI PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 380740

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other