BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUM INSERT S/36+6 TO FIT IN 36 CUP CONST

    MDR report key: 10055548 · Received May 14, 2020

    Report

    Report Number
    1220246-2020-01831
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 14, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867061323
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS NEEDED; THE ORIGINAL DOS WAS (B)(6) 2019 (NO EXACT DATE KNOWN), THE CASE WAS A REVERSE SHOULDER WITH MODULAR GLENOID SYSTEM. THE PATIENT WAS EXPERIENCING PAIN AND X-RAY SHOWED THAT THE WHOLE CONSTRUCT HAS DISLOCATED. IT IS NOT KNOWN IF THE PATIENT WAS NON-COMPLIANT. ON (B)(6) 2020, THEY REMOVED AR-9503S-06C HUMERAL INSERT; IT WAS THE ONLY PART FROM THE ORIGINAL SURGERY THAT WAS REMOVED; IT WAS REPLACED WITH AR-9555-06 REVERS SPACER AND AR-9503S-03C HUMERAL INSERT. PATIENT IS MALE, (B)(6) YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523152 HUM INSERT S/36+6 TO FIT IN 36 CUP CONST SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. HUM INSERT S/36+6 TO FIT IN 36 CUP CONST UNKNOWN 00888867061323

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other