BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMELOCK REVERSED

    MDR report key: 18913731 · Received March 15, 2024

    Report

    Report Number
    3014128390-2024-00016
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    October 26, 2023
    Report Date
    March 15, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    PHX
    UDI-DI
    03701037309476
    PMA / PMN Number
    K192206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT MIXUP OCCURRED AT PACKAGING FACILITY, WHICH HAS BEEN ISSUED A SCAR TO INVESTIGATE THE ERROR AND PREVENT RE-OCCURANCE. PACKAGING FACILITY COMPLETED THEIR INVESTIGATION AND FX ACCEPTED THEIR FINDINGS ON 15-MAR-24.

    Description of Event or Problem · 0

    A 40 MM CENTERED GLENOSPHERE WAS PRESENT IN 32 MM CENTERED GLENOSPHERE PACKAGING. PACKAGING INFORMATION: REF 105-3210 LOT: U0248. ITEM WAS 105-4010, A ONE-OF-A-KIND TEST PART. NO SURGICAL DELAY, AS ANOTHER 32 MM GLENOSPHERE WAS AVAILABLE IN THE KIT. A SCAR WAS ISSUED TO MEDICAL GROUP UNDER SCAR 24-08. MEDICAL GROUP'S NUMBER IS REC 23-10-008. ASSOCIATED WITH NC 23-0656. MEDICAL GROUP'S INVESTIGATED WAS COMPLETED AND ACCEPTED BY FX ON 15-MAR-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875408 HUMELOCK REVERSED REVERSE SHOULDER PROSTHESIS PHX FX SHOULDER SOLUTIONS DALLAS U0248 03701037309476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown