BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20522342 · Received October 24, 2024

    Report

    Report Number
    3005180920-2024-00862
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 27, 2024
    Report Date
    October 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    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 04 OCT 2024: LOT 2347108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-FEBR-2024. EXPIRATION DATE: 2029-02-17. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 04 OCT 2024: REVERSE SHOULDER SYSTEM 04.01.0270 SENSITIN GLENOSPHERE 39XØ24.5 (K203755) LOT 2315920: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEBR-2024. EXPIRATION DATE: 2029-01-28. 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.

    Description of Event or Problem · 0

    AT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION BETWEEN LINER AND GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, BASEPLATE, SCREWS AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579515 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM LOT. 234710 PHX MEDACTA INTERNATIONAL SA 04.01.0124 2347108 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention