BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11847668 · Received May 19, 2021

    Report

    Report Number
    3005180920-2021-00392
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 19, 2021
    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 30 APRIL 2021: LOT 173417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2017. EXPIRATION DATE: 2022-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM GLENOSPHERE, UNKNOWN REFERENCE AND LOT NUMBER.

    Description of Event or Problem · 1

    3 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY THE SURGEON REPORTED THAT THE JOINT LUXATED (GLENOSPHERE FROM THE LINER). THEREFORE HE DECIDED TO REVISE THE REVERSE METAPHYSIS (FROM +0/0 TO +9/0) AND LINER. GLENOSPHERE LOT NUMBER AND REFERENCE ARE UNKNOWN AND WILL NOT BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744841 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 173417 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention