BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5

    MDR report key: 16813632 · Received April 26, 2023

    Report

    Report Number
    3005180920-2023-00310
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728065
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2117351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2022. EXPIRATION DATE: 2027-FEB-13. 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 8 MONTHS AFTER THE PRIMARY RSA SURGERY DUE TO GLENOSPHERE DISASSOCIATION FROM THE BASEPLATE. ACCORDING TO REPORT, THE GLENOSPHERE SCREW WAS FOUND INTACT DURING THE REVISION. THREE POLYAXIAL LOCKING SCREWS WERE USED DURING THE PRIMARY SURGERY; DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THE LOCKING SCREWS WERE NOT LOCKED. THE SURGEON REVISED THE METAPHYSIS, LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSES FOR DISASSOCIATION CANNOT BE DETERMINED WITH CERTAINTY WITH THE ELEMENTS AT HAND. NORMALLY, THIS HAPPENS IF THE TAPER SPIGOT OF THE BASEPLATE COULD NOT ENGAGE FULLY THE GLENOSPHERE MATCHING TAPER. AMONG THE POSSIBLE REASONS FOR SUCH AN OCCURRENCE MAY BE A BASEPLATE SCREW HEAD PROTRUDING FROM THE BASEPLATE SURFACE, AND PREVENTING THE GLENOSPHERE TO REACH ITS FINAL SEATING. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058 ) LOT. 2006584 LOT 2006584: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2020. EXPIRATION DATE: 2025-OCT-06. 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

    REVISION SURGERY PERFORMED 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO GLENOSPHERE DISASSOCIATION FROM BASEPLATE (THE GLENOSPHERE SCREW WAS FOUND INTACT DURING THE REVISION). THREE POLYAXIAL LOCKING SCREWS WERE USED DURING THE PRIMARY SURGERY; DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THE LOCKING SCREWS WERE NOT LOCKED. THE SURGEON REVISED THE METAPHYSIS, LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THE GLENOSPHERE GUIDE WAS USED DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791524 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5 SHOULDER LATERALIZED GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0207 2117351 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention