BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5

    MDR report key: 15028118 · Received July 15, 2022

    Report

    Report Number
    3005180920-2022-00539
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728072
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-JUN-2022: LOT 2003816A: (B)(4) MANUFACTURED AND RELEASED ON 20-JAN-2021. EXPIRATION DATE: 2026-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LOT 2003816: 11 ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2020. EXPIRATION DATE: 2025-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 23-JUN-2022: REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT 1906800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2020. EXPIRATION DATE: 2025-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION 8 MONTHS AFTER THE PRIMARY RSA IN A MALE PATIENT DUE TO THE DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. FROM THE RADIOGRAPHIC IMAGES, IT IS VISIBLE THE GLENOPHERE DISSOCIATED FROM THE BASEPLATE. THIS EVENT POSSIBLY HAPPENED DUE TO THE FACT THAT ONE OF THE BONE SCREWS COULD NOT REACH THE FINAL POSITION AND THIS PREVENTED THE GLENOSPHERE FROM FINDING PERFECT STABILITY ON THE LATERAL SURFACE ON THE TAPER SPIGOT OF BASEPLATE, DESPITE OF CENTRAL GLENOPHERE SCREW BEING PROPERLY TIGHTENED. THE SURGEON REVISED THE GLENOSPHERE, SCREW AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    AT ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. THE SURGEON REVISED THE GLENOSPHERE, SCREW AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756522 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0208 2003816A 07630040728072

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R