BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER - TINBN COATING

    MDR report key: 23070931 · Received September 17, 2025

    Report

    Report Number
    3005180920-2025-00902
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630345709004
    PMA / PMN Number
    K203755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 SEPT 2025 REVERSE SHOULDER SYSTEM 04.01.0278 SENSITIN LAT. GLENOSPHERE 36XØ24.5 (K203755) LOT. 2305244: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 JUNE 2023. EXPIRATION DATE: 07-JUNE-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. ADDITIONAL DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2400593: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2024. EXPIRATION DATE: 02-APRIL-2029. 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. CONCLUSION: THE SURGEON REVISED THE LINER AND GLENOSPHERE HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AFTER 8 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY, AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE GLENOSPHERE AND LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640420 SHOULDER - TINBN COATING SENSITIN LAT. GLENOSPHERE 36XØ24.5 KWS MEDACTA INTERNATIONAL SA 04.01.0278 2305244 07630345709004

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention