BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITI SHOULDER SYSTEM

    MDR report key: 6178329 · Received December 15, 2016

    Report

    Report Number
    3004983210-2016-00053
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 1, 2016
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    PMA / PMN Number
    K060988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE IMPLANTED COMPONENTS WERE REMOVED AND REPLACED DUE TO "LOOSENING/LYSIS". NO FURTHER PATIENT COMPLAINTS HAVE BEEN REPORTED IN RELATION TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828881 AFFINITI SHOULDER SYSTEM SHOULDER PROSTHESIS KWS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention AEQUALIS STEM AND HUMERAL HEAD