BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID RECONSTRUCTION SYSTEM

    MDR report key: 23290524 · Received October 15, 2025

    Report

    Report Number
    3005180920-2025-01013
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630345710338
    PMA / PMN Number
    K213459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2025: REVERSE SHOULDER SYSTEM 04.01.0304 GRS BASEPLATE 24.5X30+3MM (K213459) LOT: 2219484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APRIL-2023. EXPIRATION DATE: 04-APRIL-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENT DURING THE REVIEW PERIOD. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2025: REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 (K170452) LOT: 2240236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 06-NOV-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENT DURING THE REVIEW PERIOD. REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 (K170452) LOT: 179107A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2023. EXPIRATION DATE: 29-JAN-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENT DURING THE REVIEW PERIOD. CONCLUSION: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED FOR THIS CASE, WHILE THE CURRENT ANALYSIS HAS NOT IDENTIFIED A SYSTEMIC DEFICIENCY OR POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE PATIENT UNDERWENT PRIMARY SURGERY WITH MY SHOULDER PLANNING AND GRS USING A BONE GRAFT TO CORRECT GLENOID RETROVERSION. THE CONSTRUCT WAS STABLE AND THE PATIENT WAS DOING WELL. DURING A FOLLOW-UP VISIT, IT WAS OBSERVED THAT THE GRAFT HAD RESORBED, LEADING TO GLENOID LOOSENING AND THE BREAKAGE OF TWO POLYAXIAL SCREWS. ON (B)(6) 2025, THE IMPLANTS WERE REMOVED AND REPLACED WITH A CEMENT SPACER TO ENABLE CT SCAN PLANNING FOR A CUSTOM-MADE GLENOID IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338704 GLENOID RECONSTRUCTION SYSTEM GRS BASEPLATE - Ø24.5X30 +3MM PHX MEDACTA INTERNATIONAL SA 04.01.0304 2219484 07630345710338

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention