BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER HUMERAL HEAD

    MDR report key: 250525 · Received November 16, 1999

    Report

    Report Number
    2243265-1999-00080
    Event Type
    Injury
    Date Received
    November 16, 1999
    Date of Event
    July 1, 1997
    Report Date
    November 15, 1999
    Manufacturer
    HOWMEDICA INC
    Product Code
    HSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    HUMERAL HEAD FOUND TO BE LOOSE FROM HEMERAL COMPENENT. REAPPLICATION DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOULDER HUMERAL HEAD Implant IMPLANT HSD HOWMEDICA INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention