BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNR PR1 STEM 135X33MM SM

    MDR report key: 165905 · Received April 29, 1998

    Report

    Report Number
    2219689-1998-00263
    Event Type
    Malfunction
    Date Received
    April 29, 1998
    Report Date
    April 29, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A POWERED SUBSTANCE WAS FOUND TO BE ATTACHED TO THE STEM WHEN THE PACKAGE WAS OPENED. THE STEM WAS IMPLANTED AFTER WASHING IN A FORMALIN AND SALINE SOLUTION. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HNR PR1 STEM 135X33MM SM Implant IMPLANT KWY HOWMEDICA INC. NA EPGOA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other