BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 15779271 · Received November 11, 2022

    Report

    Report Number
    3005180920-2022-00860
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 OCTOBER 2022: LOT 2105861: 194 ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2021. EXPIRATION DATE: 2026-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 27 OCTOBER 2022 ON REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058) LOT. 2110370 LOT 2110370: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 73 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS FROM PRIMARY IT WAS OBSERVED THAT THE BASEPLATE AND GLENOSPHERE WERE POSITIONED VERY SUPERIOR AND NEEDED TO BE REVISED. THE CAUSE OF THIS IS UNKNOWN. THE SURGEON REVISED THE BASEPLATE AND GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285906 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0169 2105861 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention