BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+3MM

    MDR report key: 10926442 · Received December 1, 2020

    Report

    Report Number
    3005180920-2020-00857
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 NOVEMBER 2020: LOT 1910876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 15 NOVEMBER 2020: REVERSE SHOULDER SYSTEM 04.01.0111 HUMERAL REVERSE METAPHYSIS +9MM/0¿ (K170452) LOT 1910876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2020. EXPIRATION DATE: 2025-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, ONE MONTH AFTER PRIMARY SURGERY, DUE TO IMPLANT DISLOCATION (GLENOSPHERE FROM LINER). METAPHYSIS (+9MM FLAT REPLACED WITH +9MM +20R) AND LINER (+3MM 39 REPLACED WITH+6MM 39) HAVE BEEN SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392710 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+3MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 1910876 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention