BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5

    MDR report key: 11153954 · Received January 12, 2021

    Report

    Report Number
    3005180920-2021-00045
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    December 24, 2020
    Report Date
    February 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706575
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE VISUAL INSPECTION WAS PERFORMED ON WEDNESDAY, 27TH JANUARY 2021 BY MEDACTA R&D DEPARTMENT. THE LINER DOES NOT PRESENT ANY SIGNS OF DAMAGE. THE GLENOSPHERE IS PARTIALLY SCRATCHED AND DULL, PROBABLY DUE TO FRICTION WITH THE "REVERSE METAPHYSIS" OCCURRED AFTER THE DISLOCATION. THE REVERSE METAPHYSIS SHOWS MINOR BONE AND HYDROXYAPATITE RESIDUALS ON THE COATED SURFACE. THE OUTER CYLINDRIAL SURFACE IS DAMAGED ON THE MEDIAL SIDE PRESUMABLY DUE TO CONTACT WITH THE GLENOSPHERE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12-JAN-2021: LOT 1910953: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2020. EXPIRATION DATE: 24-MAY-2025. 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 EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT. 1907768. BATCH REVIEW PERFORMED ON 12 JANUARY 2021: LOT 1907768: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2019. EXPIRATION DATE: 2024-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY DUE TO SHOULDER LUXATION (INSTABILITY) OF THE GLENOSPHERE FROM THE LINER, 1 MONTH AFTER THE PREVIOUS OPERATION. DURING THE REVISION SURGERY THE METAPHYSIS, GLENOSPHERE AND LINER WERE REVISED. THE NEW GLENOSPHERE IS LATERALIZED AND THE LINER IS +3MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54093 REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0170 1910953 07630040706575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention