BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS REVERSED INSERT

    MDR report key: 6197754 · Received December 22, 2016

    Report

    Report Number
    3000931034-2016-00223
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386940538
    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 REVISION SURGERY AT 14 MONTHS POST-OPERATIVE FOR INSTABILITY/DISLOCATION. STEM AND BASEPLATE REMAINED IMPLANTED FROM PREVIOUS SURGERY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850735 AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS REVERSED INSERT SHOULDER JOINT POLYMER PROSTHESIS KWS TORNIER S.A.S. DIA.36 +9 03700386940538

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other