BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23858634 · Received December 20, 2025

    Report

    Report Number
    3005180920-2025-01264
    Event Type
    Injury
    Date Received
    December 20, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 DECEMBER 2025 REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER D 39/+3MM (K170452) LOT 2409260: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2024. EXPIRATION DATE: 2029-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0279 SENSITIN LAT. GLENOSPHERE 39XD 24.5 (K203755) LOT 2302405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2023. EXPIRATION DATE: 2028-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH THREE SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:ALTHOUGH A PRECISE ROOT CAUSE CANNOT BE ESTABLISHED, THESE EVENTS ARE GENERALLY RELATED TO INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER SURGERY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY MANUFACTURING-RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY RIGHT SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6)2025, THE PATIENT CAME IN REPORTING PAIN AND WHEN REVIEWING THE PATIENT’ SIMPLANTS TO PREPARE FOR THE REVISION, THE REPOBSERVED THAT A 27 GLENOSPHERE WAS IMPLANTED WITH A 24.5MM BASEPLATE DURING THE PRIMARY (WHICH IS A NON-COMPATIBLE COMBINATION AS REPORTED IN THE SURGICAL TECHNIQUE). IT IS UNKNOWN HOW OR WHY THIS OCCURRED. GLENOSPHERE, LINER AND METAPHYSIS REVISED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME DUE TO DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER TO A CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312576 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2409260 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention