BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM

    MDR report key: 10926464 · Received December 1, 2020

    Report

    Report Number
    3005180920-2020-00863
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 NOVEMBER 2020: LOT 2001993: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-11. 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: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 1910952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2020. EXPIRATION DATE: 2025-05-24. 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

    AFTER THE PRIMARY SHOULDER SURGERY, WHEN THE PATIENT WAS IN POST-OP RECOVERY AND WAS BEING MOVED FROM OPERATING ROOM BED TO HOSPITAL BED, THE PATIENT'S GLENOSPHERE SUBLUXED FROM THE LINER. THE SURGEON REVISED THE GLENOSPHERE - 36X24.5 TO A GLENOSPHERE - 39X24.5, THE HUMERAL REVERSE METAPHYSIS +0MM/0° WITH A HUMERAL REVERSE METAPHYSIS +9MM/0°, AND THE HUMERAL REVERSE HC LINER 36/+3MM WITH A HUMERAL REVERSE HC LINER 39/+0MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393317 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM SHUOLDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0120 2001993 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention