BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD ST. 6X115 W/ALIGN HOLE

    MDR report key: 3133201 · Received May 29, 2013

    Report

    Report Number
    0001825034-2013-01673
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATIONS. IT WAS NOTED THE STEM SAT PROUD. PATIENT WAS REVISED TO A REVERSE SHOULDER FOR STABILITY. THE STEM AND HEAD WERE REMOVED AND REPLACED WITH COMPREHENSIVE REVERSE SHOULDER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236763 BIO-MOD ST. 6X115 W/ALIGN HOLE PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R