BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M BRAND MODULAR SHOULDER SYSTEM STEMS

    MDR report key: 174821 · Received June 25, 1998

    Report

    Report Number
    2110898-1998-00013
    Event Type
    Malfunction
    Date Received
    June 25, 1998
    Manufacturer
    3M HEALTH CARE LTD. - HELLABY
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LABELING TO BE INCORRECT. THE STEM THAT WAS IN THE BOX WAS NOT A SIZE 14MM; RATHER IT WAS A SIZE 16MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M BRAND MODULAR SHOULDER SYSTEM STEMS Implant MODULAR HUMERAL STEM 125 HSD 3M HEALTH CARE LTD. - HELLABY 125 96G398

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other