BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

    MDR report key: 16874674 · Received May 5, 2023

    Report

    Report Number
    3005180920-2023-00300
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 7, 2023
    Report Date
    May 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715478
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 APRIL 2023. LOT 1904749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-NOV-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 1 YEAR AND 7 MONTHS AFTER THE PRIMARY RSA SURGERY, DUE TO A MALPOSITIONED BASEPLATE AND GLENOSPHERE ( THE BLOCK WAS FOUND TILTED SUPERIORLY). THE CAUSES FOR THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY WITH THE ELEMENTS AT HAND. THIS MAY HAVE HAPPENED DUE TO AN IMPINGEMENT OF THE HUMERAL STEM WITH THE BASEPLATE WHICH MAY HAVE CAUSED THE MOVEMENT OF THE BASEPLATE AND MALPOSITIONING OF THE GLENOIDAL IMPLANT. IF THE METAPHYSIS IS MALPOSITIONED, IT COULD PRY UP THE GLENOSPHERE WITH THE BASEPLATE ATTACHED. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 11 APRIL 2023 ON REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2005600 LOT 2005600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2020. EXPIRATION DATE: 2025-SEP-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED BASEPLATE AND GLENOSPHERE (TILTED SUPERIOR) AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA METAPHYSIS, BASEPLATE, SCREWS AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575141 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30 SHOULDER REVERSE GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0191 1904749 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention