BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22060633 · Received May 21, 2025

    Report

    Report Number
    3005180920-2025-00472
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 19, 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 8 MAY 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31/01/2024. EXPIRATION DATE: 15/01/2029. 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. ADDITIONAL DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 2314461 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08/08/2023. EXPIRATION DATE: 22/07/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT. 2242354 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07/03/2023. EXPIRATION DATE: 19/02/2028. 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 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2315418 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08/11/2023. EXPIRATION DATE: 15/10/2028. 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 CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645172 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2335874A 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention