BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24454902 · Received February 26, 2026

    Report

    Report Number
    3005180920-2026-00131
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 6, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630542714627
    PMA / PMN Number
    K231911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 FEBR 2026. REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 10° (K231911) LOT 2339030: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEPT-2024. EXPIRATION DATE: 2029-AUG-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. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2433334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2025. EXPIRATION DATE: 2030-APR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER D 36/+6MM (K170452) LOT. 2246172: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-APR-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. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - D 36X24.5 (K170452) LOT. 2430413: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2023. EXPIRATION DATE: 2030-FEB-17. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY RIGHT SHOULDER ON (B)(6) 2019 WITH AN ANATOMICAL SHOULDER SYSTEM. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED ROTATOR CUFF AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMIC SHOULDER TO REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520018 SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10° PHX MEDACTA INTERNATIONAL SA 04.01.0400 2339030 07630542714627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention