BEUDAMED
    FDA Adverse Event Summary report: N

    HUMERAL INSERT METAL BACK ARROW

    MDR report key: 6050555 · Received October 24, 2016

    Report

    Report Number
    3003898228-2016-00009
    Date Received
    October 24, 2016
    Date of Event
    June 29, 2016
    Report Date
    January 6, 2017
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWS
    PMA / PMN Number
    K112193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION : THIS INCIDENT WILL BE INCLUDED IN RISK MANAGEMENT TO REVIEW THE FREQUENCY OF OCCURRENCE.

    Description of Event or Problem · 1

    DISASSEMBLING OF THE POLYETHYLENE AND THE METAL BASE OF SHOULDER PROTHESIS IMPLANTED THE (B)(6) 2010. REOPERATION : (B)(6) 2016.

    Description of Event or Problem · 1

    DISASSEMBLING OF THE POLYETHYLENE AND THE METAL BASE OF SHOULDER PROTHESIS IMPLANTED THE (B)(6) 2010. REOPERATION : (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702132 HUMERAL INSERT METAL BACK ARROW ARROW PROTESIS SHOULDER KWS FH INDUSTRIE 257057 903132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other