BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22017270 · Received May 14, 2025

    Report

    Report Number
    3005180920-2025-00421
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 14, 2025
    Report Date
    May 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040715928
    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 14-05-2025. LOT 2205999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-05-2022 EXPIRATION DATE: 2027-04-27. 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. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0095 METAL HUMERAL HEAD Ø50 (K170910) LOT 2003885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-12-2020 EXPIRATION DATE: 2025-11-25. 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 04.01.0089 DOUBLE ECCENTER (K170910) LOT 2239895: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-11-2022 EXPIRATION DATE: 2027-11-16. 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 04.01.0028 HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-11 (K170910) LOT 2116325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-04-2022 EXPIRATION DATE: 2027-03-22. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    IN (B)(6) 2023 THE PATIENT UNDERWENT A TSA, THE SURGEON AIMED AT IMPLANTING A REVERSE SHOULDER BUT THE IMPLANTATION FAILED DUE TO POOR GLENOID BONE STOCK. THE SURGEON CONVERTED THE SURGERY IN A HEMI-ARTHROPLASTY. IN (B)(6) 2025 THE PATIENT REPORTED PAIN OF UNKNOWN CAUSE, THE SURGEON REVISED THE PATIENT TO A REVERSE SHOULDER (COMPETITOR IMPLANTS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118579 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 KWS MEDACTA INTERNATIONAL SA 04.01.0184 2205999 07630040715928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention