BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 9494238 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01075
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 28, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 6 DECEMBER 2019. LOT 189744: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2019. EXPIRATION DATE: 2024-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT. 1904752. BATCH REVIEW PERFORMED ON 6 DECEMBER 2019. LOT 1904752: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2019. EXPIRATION DATE: 2024-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. FEW DAYS AFTER PRIMARY RSA THE GLENOID COMPONENT DISLOCATED AND THE SCAPULAR BONE WAS FRACTURED. THIS IS MOST PROBABLY DUE TO THE WEAK QUALITY OF THE BONE. THE IMPLANTS SEEM TO HAVE BEEN CORRECTLY POSITIONED AND THERE IS NO DISCERNIBLE HINT OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL SURGERY PERFORMED 7 DAYS AFTER THE PRIMARY DUE TO DISLOCATION OF THE BASEPLATE AND BREAKAGE OF THE POSTERIOR HALVE PORTION OF THE GLENOID. THE PATIENT HAS A WEAK BONE. NO INFORMATION IF IT WAS CAUSED BY TRAUMA. THE GLENOID BASEPLATE, LINER, SCREWS AND METAPHYSIS WERE EXPLANTED WITHOUT IMPLANTING NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287593 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 REVERSE GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 189744 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention