BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 21771299 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00269
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040706032
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 MARCH 2025. LOT 2217103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 18 MARCH 2025 ON REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2313417. LOT 2313417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2023. EXPIRATION DATE: 2028-SEP-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 18 MARCH 2025 ON REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 2306772. LOT 2306772: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2023. EXPIRATION DATE: 2028-JUL-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. BATCH REVIEW PERFORMED ON 18 MARCH 2025 ON REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058) LOT. 2300936. LOT 2300936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2023. EXPIRATION DATE: 2028-07-24. 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. BATCH REVIEW PERFORMED ON 18 MARCH 2025 ON REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2309372. LOT 2309372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUN-2023. EXPIRATION DATE: 2028-05-14. 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. 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

    REVISION SURGERY AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY 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
    2323323 ANATOMIC SHOULDER PROSTHESIS REVERSE SHOULDER SYSTEM STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 9 KWS MEDACTA INTERNATIONAL SA 04.01.0004 2217103 07630040706032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention