BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED PROSTHESIS

    MDR report key: 7823440 · Received August 28, 2018

    Report

    Report Number
    3000931034-2018-00114
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 7, 2018
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K081059
    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 : "DOES ARM LENGTHENING AFFECT THE FUNCTIONAL OUTCOME IN ONLAY REVERSE SHOULDER ARTHROPLASTY?" WERNER BS ET AL., J SHOULDER ELBOW SURG, 2017, 26(12):2152-2157.

    Description of Event or Problem · 1

    FROM LITERATURE: "DOES ARM LENGTHENING AFFECT THE FUNCTIONAL OUTCOME IN ONLAY REVERSE SHOULDER ARTHROPLASTY?" WERNER BS ET AL., J SHOULDER ELBOW SURG, 2017, 26(12):2152-2157. 8 COMPLICATIONS: 3 FRACTURE OF THE ACROMION OR SCAPULAR SPINE (AT 2, 3 AND 36 MONTHS), TREATED CONSERVATIVELY IN AN ABDUCTION BRACE FOR 6 WEEKS, 2 DISLOCATIONS (AT 3 AND 18 MONTHS), TREATED WITH OPEN REDUCTION AND EXCHANGE OF THE PE INSERT, 1 POST-OPERATIVE BRACHIAL PALSY REVISED 8 WEEKS LATER, TREATED BY NEUROLYSIS AND REVISION OF THE HUMERAL COMPONENT, 1 ASEPTIC LOOSENING (AT 25 MONTHS), 1 CHRONIC INFECTION (AT 21 MONTHS), TREATED WITH ARTHROSCOPIC LAVAGE AND ANTIBIOTIC THERAPY FOR 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663563 AEQUALIS REVERSED PROSTHESIS SHOULDER PROSTHESIS KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other