BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21926123 · Received April 29, 2025

    Report

    Report Number
    3005180920-2025-00372
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 APRIL 2025. LOT 2402711: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2024. EXPIRATION DATE: 2029-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 15 APRIL 2025 ON REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM (K170452) LOT. 2312095. LOT 2312095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2023. EXPIRATION DATE: 2028-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 15 APRIL 2025 ON REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2344621. LOT 2344621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MARCH-2024. EXPIRATION DATE: 2029-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 15 APRIL 2025 ON REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE, Ø24.5X20, FULL WEDGE 10 (K231911) LOT. 2307084. LOT 2307084: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MARCH-2024. EXPIRATION DATE: 2029-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. 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

    AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463301 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2402711 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention