BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M BRAND METAL IMPLANTS

    MDR report key: 162349 · Received April 9, 1998

    Report

    Report Number
    2110898-1998-00009
    Event Type
    Injury
    Date Received
    April 9, 1998
    Manufacturer
    3M HEALTH CARE LTD. - HELLABY
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED TO 3M: CUSTOMER REPORTED TWO WEEKS AFTER RECEIVING THE 3M MODULAR SHOULDER PROSTHESIS THE HEAD LOOSENED FROM THE STEM. THE PT UNDERWENT ANOTHER OPERATION WITH A NEW HEAD FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M BRAND METAL IMPLANTS Implant HUMERAL HEAD CO CHROME, SIZE 18 HSD 3M HEALTH CARE LTD. - HELLABY * 97 DO 48

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention