BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22326365 · Received June 25, 2025

    Report

    Report Number
    3005180920-2025-00563
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 MAY 2025. LOT: 2434142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2025. EXPIRATION DATE: 2030-03-18. 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. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE - Ø24.5X15 LOT: 2429981 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2025. EXPIRATION DATE: 2030-02-05. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING-RELATED ISSUE OR SYSTEMIC DEFICIENCY. ALTHOUGH IT CANNOT BE CONFIRMED, THE ISSUES REPORTED MAY HAVE BEEN CAUSED BY A SUBOPTIMAL ALIGNMENT BETWEEN THE GLENOSPHERE AND THE BASEPLATE.

    Description of Event or Problem · 0

    WHEN CONNECTION THE GLENOSPHERE TO THE BASEPLATE, IT DID NOT FULLY SEAT. THE GLENOSPHERE SCREW LOCKED APPROXIMATELY 2-3 MM BEFORE FULLY ENGAGING IN THE BASEPLATE. THE GLENOSPHERE WAS REINSERTED AFTER CLEANING AROUND THE BASEPLATE, BUT THE SITUATION DID NOT CHANGE. WHEN RECHECKING THE SCREW HEAD, THE TIP OF THE SCREW SHOWED SILVER WEAR MARKS. SO, THE SCREW ALONE WAS INSERTED. THEN, A GRINDING NOISE WAS HEARD, SO IT WAS REPLACED WITH A NEW SCREW (REF. 04.01.0177, LOT: 2418605). THE GLENOSPHERE GUIDE (REF 04.01.10.0432) WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE 30 MINUTES DELAY TO INSERT THE SCREW INTO THE BASEPLATE (TOT TIME 2.5 HOURS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998594 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5 PHX MEDACTA INTERNATIONAL SA 04.01.0169 2434142 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other