BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25

    MDR report key: 15796635 · Received November 15, 2022

    Report

    Report Number
    3005180920-2022-00861
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706421
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-NOV-2022. LOT 2110379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2021. EXPIRATION DATE: 2026-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. REVISION 7 MONTHS AFTER THE PRIMARY SURGERY IN A 89 YEAR OLD FEMALE PATIENT DUE TO MOBILIZATION OF THE BASEPLATE THAT CAUSED THE JOINT LUXATION. ACCORDING TO THE REPORT, THERE WAS NO FALL OR INFECTION. IN THE PRIMARY SURGERY, AN AUTOGRAFT WAS USED. IT MAY BE POSSIBLE THAT THERE WAS NO INTEGRATION AND THEREFORE THE MOBILIZATION OF THE GRAFT AND THE BASEPLATE. ACCORDING TO THE REPORT, THE AUTOGRAFT WAS OF POOR QUALITY AS THE BONE OF THE PATIENT WHERE IT CAME FROM. THIS PROBLEM IS NOT RELATED TO A FAULTY IMPLANT.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO MOBILIZATION OF THE BASEPLATE WITH AUTOGRAFT THAT CAUSED THE JOINT LUXATION, 7 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT HAS POOR BONE QUALITY. THE AUTOGRAFT WAS NOT OF GOOD QUALITY. ALL IMPLANTS, EXCEPT FOR THE HUMERAL SHORT STEM, WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020739 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25 SHOULDER GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0155 2110379 07630040706421

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention