BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS PERFORM GLENOID PEGGED

    MDR report key: 7819736 · Received August 27, 2018

    Report

    Report Number
    3000931034-2018-00110
    Event Type
    Injury
    Date Received
    August 27, 2018
    Report Date
    August 7, 2018
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K111902
    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 : "RADIOGRAPHIC COMPARISON OF FINNED, CEMENTLESS CENTRAL PEGGED GLENOID COMPONENT AND CONVENTIONAL CEMENTED PEGGED GLENOID COMPONENT IN TOTAL SHOULDER ARTHROPLASTY: A PROSPECTIVE RANDOMIZED STUDY" KILIAN C ET AL., J SHOULDER ELBOW SURG, 2018 JUN;27(6S): S10-S16.

    Description of Event or Problem · 1

    FROM LITERATURE: " RADIOGRAPHIC COMPARISON OF FINNED, CEMENTLESS CENTRAL PEGGED GLENOID COMPONENT AND CONVENTIONAL CEMENTED PEGGED GLENOID COMPONENT IN TOTAL SHOULDER ARTHROPLASTY: A PROSPECTIVE RANDOMIZED STUDY" KILIAN C ET AL., J SHOULDER ELBOW SURG, 2018 JUN;27(6S): S10-S16. ONE COMPLICATION IN THE PERFORM GROUP: 1 INTROPERATIVE NONDISPLACED GREATER TUBEROSITY FRACTURE THAT DID NOT REQUIRE FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660543 AEQUALIS PERFORM GLENOID PEGGED SHOULDER PROSTHESIS KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other