BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24454894 · Received February 26, 2026

    Report

    Report Number
    3005180920-2026-00124
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 29, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706391
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 FEBR 2026 GLENOID BASEPLATE - D 24.5X25 (K170452) LOT 2413518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEPT-2024. EXPIRATION DATE: 2029-AUG-20. 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. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - D 36X24.5 (K170452) LOT 2519720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2025. EXPIRATION DATE: 2030-OCT-07. 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. (TWO DEVICES INVOLVED IN THIS CASE) REVERSE SHOULDER SYSTEM 64.01.9009 SF GLENOSPHERE SCREW LOT 2423197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (TWO DEVICES INVOLVED IN THIS CASE) INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. THE CONNECTION BETWEEN THE BASEPLATE AND THE GLENOSPHERE IS ACHIEVED THROUGH A CONICAL CONNECTION BETWEEN THE TAPERS OF THE COMPONENTS AND SECURED BY THE USE OF A SAFETY SCREW. THE SAFETY SCREW HAS TO BE INSERTED AFTER THE TWO IMPLANTS HAVE ALREADY BEEN COUPLED VIA THE TAPER. IN ORDER TO BE CORRECTLY INSERTED, THE AXES OF THE TWO IMPLANTS MUST BE ALIGNED. TO ACHIEVE THIS, THE USE OF AN ALIGNMENT GUIDE IS REQUIRED. THE GUIDE CANNOT BE REPLACED BY USING THE SCREW AS A GUIDE. THE SCREW DOES NOT PROVIDE ADEQUATE GUIDANCE TO SEAT THE GLENOSPHERE CORRECTLY ONTO THE BASEPLATE. FURTHERMORE, USING THE SCREW IN THIS WAY INTERFERES WITH THE PROPER ASSEMBLY OF THE GLENOSPHERE TO THE IMPACTOR (04.01.10.0432).

    Description of Event or Problem · 0

    AFTER IMPACTING THE GLENOSPHERE ONTO THE BASEPLATE, THE SURGEON ATTEMPTED TO INSERT THE SCREW, BUT WAS UNSUCCESSFUL. SEVERAL ATTEMPTS, INCLUDING THE USE OF ANOTHER GLENOSPHERE OF THE SAME LOT, ALSO FAILED. THE SURGEON DECIDED TO REPLACE THE BASEPLATE. HOWEVER, DURING ITS REMOVAL, THE GLENOID FRACTURED, NECESSITATING THE IMPLANTATION OF A CTA-TYPE ENDOPROSTHESIS. SUBSEQUENTLY, OUTSIDE THE OPERATIVE FIELD, THE FIT BETWEEN THE GLENOSPHERE AND THE BASEPLATE WAS TESTED AGAIN, BUT EACH TIME THE CENTRAL SCREW WAS TIGHTENED, THE GLENOSPHERE WOULD SLIP OUT OF THE BASEPLATE. DELAY TIME: APPROXIMATELY 30 MINUTES (TOTAL DURATION 1.5 HOURS). NO INFO REGARDING PATIENT`S BONE QUALITY. NO GUIDE WAS USED FORGLENOSPHEREINSERTION.RETENTIVE GLENOSPHERE IMPACTOR (REF 04.01.10.0432) USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281491 SHOULDER SYSTEM GLENOID BASEPLATE - Ø24.5X25 PHX MEDACTA INTERNATIONAL SA 04.01.0152 2413518 07630040706391

    Patients

    Seq Age Sex Outcome Treatment
    1