BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS

    MDR report key: 7823444 · Received August 28, 2018

    Report

    Report Number
    3000931034-2018-00115
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 7, 2018
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K122698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE SOURCE OF THIS REPORT LITERATURE : "IS RADIOGRAPHIC MEASUREMENT OF ACROMIOHUMERAL DISTANCE ON ANTEROPOSTERIOR VIEW AFTER REVERSE SHOULDER ARTHROPLASTY RELIABLE?" WERNER BS ET AL., J SHOULDER ELBOW SURG, 2016, 25(9):E276-80.

    Description of Event or Problem · 1

    FROM LITERATURE: "IS RADIOGRAPHIC MEASUREMENT OF ACROMIOHUMERAL DISTANCE ON ANTEROPOSTERIOR VIEW AFTER REVERSE SHOULDER ARTHROPLASTY RELIABLE?" WERNER BS ET AL., J SHOULDER ELBOW SURG, 2016, 25(9):E276-80. FOUR COMPLICATIONS NECESSITATING REOPERATION IN 2 CASES: 1 DISLOCATION AT 3 MONTHS POST-OP (ORIF AND EXCHANGE OF THE PE INSERT), 1 LOW GRADE INFECTION AT 1.5 YERS POST-OP (ARTHROSCOPIC REVISION AND BIOPSY), 2 FRACTURES OF SCAPULAR SPINE TREATED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663565 AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS SHOULDER PROSTHESIS KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other