BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM

    MDR report key: 10585026 · Received September 25, 2020

    Report

    Report Number
    3005180920-2020-00638
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    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 (B)(6) 2020. LOT 1811943: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2019. EXPIRATION DATE: 2024-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2020. CONCOMITANT MEDICAL PRODUCTS: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39X027 (K170452) LOT. 174737, LOT 174737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2022-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH FOUR OTHER SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A FIRST REVISION SURGERY FROM COMPETITOR TO MEDACTA PRODUCTS ON THE (B)(6) 2020. THEN, A LUXATION OF THE SHOULDER (GLENOSPHERE FROM LINER) OCCURRED. FOLLOWING THIS EVENT, THE GLENOSPHERE WAS CHANGED FROM 39 TO 42 LATERAL GLENOSPHERE AND THE LINER WAS CHANGED FROM 039 TO A 042 LINER, 2 MONTHS AFTER PREVIOUS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053630 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 1811943 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention