BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 11899534 · Received May 28, 2021

    Report

    Report Number
    3009532798-2021-00075
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 28, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR HAS ALREADY BEEN SUBMITTED TO FDA BY THE US IMPORTER WITH REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2021 DUE TO DISLOCATION FROM NON-COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS (PATIENT REMOVED SURGICAL SLING), APPROXIMATELY 2 MONTHS AFTER PRIMARY SURGERY. SURGEON EXPLANTED THE 135/145 40/+3 STANDARD HUMERAL CUP AND REPLACED IT WITH A 36/+3 STABILITY HUMERAL CUP PLUS 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796226 HUMERIS REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS M1495

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R