BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 9

    MDR report key: 7288851 · Received February 22, 2018

    Report

    Report Number
    3005180920-2018-00081
    Event Type
    Injury
    Date Received
    February 22, 2018
    Report Date
    March 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706032
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED ON 22 MARCH 2018 BY R&D PRODUCT MANAGER: THE HUMERAL DIAPHYSIS SHOWS A PARTIAL RE-ABSORPTION OF HA. SCRATCHES, LIKELY TO BE DONE WHILE REVISING, ARE VISIBLE ON THE IMPLANTS (DIAPHYSIS AND METAPHYSIS). A POLISHED AREA IS VISIBLE ON THE MEDIAL ASPECT OF THE REVERSE METAPHYSIS, MAYBE DUE TO IMPINGEMENT IN THE ROM. THE EXPLANTED COMPONENTS DO NOT SHOW ANY SIGNS OF FAILURE THAT CAN BE ASSOCIATED TO THE SUBSIDENCE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018: LOT 172244: 41 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    STEM SUBSIDENCE AFTER ABOUT 6 WEEKS FROM TOTAL SHOULDER REPLACEMENT; REVISION SURGERY PLANNED FOR (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132128 REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 9 HUMERAL DIAPHYSIS CEMENTLESS PHX MEDACTA INTERNATIONAL SA 172244 07630040706032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention