BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22011829 · Received May 13, 2025

    Report

    Report Number
    3005180920-2025-00445
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040715935
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 MAY 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020. EXPIRATION DATE: 2025-11-17. 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. 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. ADDITIONAL INVOLVED IMPLANTS: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003852. BATCH REVIEW PERFORMED ON 02 MAY 2025. 192 ITEMS MANUFACTURED AND RELEASED ON 01-APR-2021. EXPIRATION DATE: 2026-03-19. 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. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 2101813 BATCH REVIEW PERFORMED ON 02 MAY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2021. EXPIRATION DATE: 2026-03-23. 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. REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT. 2004005 BATCH REVIEW PERFORMED ON 02 MAY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-03-16. 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. REVERSE SHOULDER SYSTEM 04.01.0192 THREADED GLENOID BASEPLATE Ø27X30 (K171058) LOT. 1906801 BATCH REVIEW PERFORMED ON 02 MAY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879805 SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12 KWS MEDACTA INTERNATIONAL SA 04.01.0185 2009931 07630040715935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention