BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM

    MDR report key: 10502563 · Received September 8, 2020

    Report

    Report Number
    3005180920-2020-00598
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 8, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 AUGUST 2020: LOT 1910872: (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 WITH ANOTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 LOT. 1811894 (K170452) BATCH REVIEW PERFORMED ON 24 AUGUST 2020: LOT 1811894: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2019. EXPIRATION DATE: 2024-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH OTHER 2 SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    LUXATION OF THE REVERSE MEDACTA SHOULDER ON 12.8.2020 (LINER FROM GLENOSPHERE), PATIENT CALLED THE SURGEON AND CAME THE SAME DAY TO THE HOSPITAL, AFTER IT COULD NOT BE REPOSITIONED BY CLOSED REDUCTION THE SURGEON DECIDED TO DO A REVISION SURGERY (2 MONTHS AFTER PRIMARY SURGERY). ONLY THE LINER WAS SWAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966737 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 1910872 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention