BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22630833 · Received July 28, 2025

    Report

    Report Number
    3005180920-2025-00715
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706421
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JULY 2025: LOT 2201537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2022. EXPIRATION DATE: 2027-05-11. 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. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 18 JULY 2025: REVERSE SHOULDER SYSTEM 04.01.0200 GLENOID POLYAXIAL NON-LOCKING SCREW - L38 (K181826) LOT 2246465: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2023. EXPIRATION DATE: 2028-01-12. 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 04.01.0199 GLENOID POLYAXIAL NON-LOCKING SCREW - L34 (K181826) LOT 2247067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-MAR-01. 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. ROOT CAUSE: THE SCREW BREAKAGE IS MOST LIKELY THE RESULT OF UNINTENDED EXCESSIVE LOADING, WHICH TYPICALLY OCCURS DUE TO A TRAUMATIC EVENT OR INSUFFICIENT OSSEOINTEGRATION OF THE BONE GRAFT. IN THIS CASE, THE FAILURE OF THE BONE GRAFT HEALING AND OSSEOINTEGRATION SEEMS TO BE THE PRIMARY FACTOR IN THE GLENOID BASEPLATE LOOSENING AND SUBSEQUENT SCREW BREAKAGE.

    Description of Event or Problem · 0

    REVISION SURGERY CASE AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY. THE GLENOID COMPONENT WAS MOBILIZED. THE BASEPLATE, SCREWS AND GLENOSPHERE ALTOGETHER WERE DETACHED FROM THE GLENOID, BUT ASSEMBLED TO EACH OTHER. ONE OF THE 2 SCREWS (UNKNOWN WITH OF THE 2 REPORTED) WAS BROKEN. SOME METALLOSIS WAS DETECTED ON THE SURFACE OF THE GLENOID. THE GLENOID COMPONENTS WERE REMOVED AND THE REVERSE METAPHYSIS AND HUMERAL PE LINER WERE REMOVED AS WELL. A SAFETY ENDOPROSTHESIS WAS IMPLANTED WITH AN ANATOMICAL METAPHYSIS (142), DOUBLE ECCENTER AND HUMERAL HEAD. THE PRIMARY WAS PERFORMED WITH A BONE GRAFT FOR GLENOID LATERALIZATION. THE ISSUE IS DUE TO A FAILURE OF THE BONE GRAFT LEADING TO ANOMALOUS SCREW LOADING AND BASEPLATE MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610661 SHOULDER SYSTEM GLENOID BASEPLATE - Ø27X25 PHX MEDACTA INTERNATIONAL SA 04.01.0155 2201537 07630040706421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention