BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS REVERSED INSERT

    MDR report key: 6119715 · Received November 22, 2016

    Report

    Report Number
    3000931034-2016-00199
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    July 22, 2016
    Report Date
    October 27, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K122698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 A PATIENT UNDERWENT A REVISION SURGERY AT 3 MONTHS POST-OP DUE TO INSTABILITY/DISLOCATION. THE IMPLANTED STEM, REVERSED TRAY, REVERSED INSERT AND GLENOID SPHERE WERE REMOVED. BASEPLATE REMAINED FROM PREVIOUS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772359 AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS REVERSED INSERT SHOULDER JOINT POLYMER PROSTHESIS KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other