BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS

    MDR report key: 7801750 · Received August 21, 2018

    Report

    Report Number
    3000931034-2018-00106
    Event Type
    Injury
    Date Received
    August 21, 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 : MEROLLA G, WALCH G, ASCIONE F, PALADINI P, FABBRI E, PADOLINO A, PORCELLINI G, J SHOULDER ELBOW SURG, 2018, 27(4):701-710. "GRAMMONT HUMERAL DESIGN VERSUS ONLAY CURVED-STEM REVERSE SHOULDER ARTHROPLASTY: COMPARISON OF CLINICAL AND RADIOGRAPHIC OUTCOMES WITH MINIMUM 2-YEAR FOLLOW-UP."

    Description of Event or Problem · 1

    FROM LITERATURE : "GRAMMONT HUMERAL DESIGN VERSUS ONLAY CURVED-STEM REVERSE SHOULDER ARTHROPLASTY: COMPARISON OF CLINICAL AND RADIOGRAPHIC OUTCOMES WITH MINIMUM 2-YEAR FOLLOW-UP" MEROLLA G. ET AL., J SHOULDER ELBOW SURG, 2018, 27(4):701-710. 7 COMPLICATIONS IN THE AEQUALIS ASCEND FLEX GROUP: 2 FRACTURES OF THE SCAPULAR SPINE AT 3 AND 23 MONTHS TREATED CONSERVATIVELY WITH SHOULDER IMMOBILIZATION FOR 4 WEEKS ;1 ACROMIAL FRACTURE AT 2 MONTHS TREATED WITH INTERNAL FIXATION ; 3 INFECTIONS (2 PATIENTS AT 1 MONTH AND 1 PATIENT AT 19 MONTHS) -> 2 TREATED WITH ANTIBIOTIC THERAPY. ON THESE 7 COMPLICATIONS 2 REQUIRED REVISION SURGERY -> 1 FOR INFECTION MANAGED BY IMPLANTING ANOTHER REVERSE PROSTHESIS AND 1 FOR DISLOCATION AT 2 MONTHS -> IMPLANTATION OF A HIGHER PE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644045 AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS SHOULDER PROSTHESIS KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other