BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24494903 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00154
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706414
    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 3 FEBRUARY 2026. REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE - D 27X15 (K170452) LOT: 2502474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2025. EXPIRATION DATE: 21-MAY-2030. 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 04.01.0173 GLENOSPHERE - D 39X27 (K170452) LOT: 2513442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2025. EXPIRATION DATE: 29-JUL-2030. 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. BATCH REVIEW OF THE SEMIFINISHED GLENOSPHERE SCREW LOT (OF REF 04.01.0173 - LOT: 2513442): REVERSE SHOULDER SYSTEM 64.01.9009 SF GLENOSPHERE SCREW LOT: 2509824: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUL-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. ROOT CAUSE:DUE TO THE LACK OF INFORMATION IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION: THE INTRA-OPERATIVE IMAGE PROVIDED UNFORTUNATELY DOES NOT ALLOW A DETAILED ASSESSMENT OF THE SCREW-BASEPLATE INTERFACE OR THE INTERNAL THREAD CONDITION; THEREFORE, IT DOES NOT PROVIDE ELEMENTS TO CLARIFY THE CAUSE OF THE EVENT. WITH THE LIMITED INFORMATION CURRENTLY AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF WHY THE GLENOSPHERE SCREW COULD NOT BE FULLY INSERTED.

    Description of Event or Problem · 0

    THE GLENOSPHERE SCREW COULD NOT BE FULLY INSERTED IN THE BASEPLATE. RESIDUAL BONE AROUND THE BASEPLATE WAS SUSPECTED, AND THE SURROUNDING AREA WAS CLEARED AGAIN, BUT THE SAME ISSUE OCCURRED. WHEN THE SCREW WAS INSERTED WITHOUT THE GLENOSPHERE AS A TEST, THE SCREW AGAIN STOPPED MIDWAY. THE SCREW WAS LEFT AT THE POINT WHERE IT STOPPED. THE SURGERY WAS COMPLETED IMPLANTING THE GLENOSPHERE WITH THE GLENOSPHERE SCREW NOT COMPLETELY SCREWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450401 SHOULDER SYSTEM GLENOID BASEPLATE - Ø27X15 PHX MEDACTA INTERNATIONAL SA 04.01.0154 2502474 07630040706414

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other