BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MSF

    MDR report key: 2358869 · Received December 5, 2011

    Report

    Report Number
    1020279-2011-00509
    Event Type
    Injury
    Date Received
    December 5, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 14, 2011
    Manufacturer
    SMITH AND NEPHEW, GERMANY
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSES FOR REVISION SURGERY CAN BE ATTRIBUTED BUT ARE NOT LIMITED TO INFECTION, POOR BONE QUALITY, INADEQUATE BONE INGROWTH, AND/OR PATIENT ANATOMY. THE PRESENCE OF AN INFECTION IS KNOWN TO REDUCE THE PH OF SURROUNDING TISSUES, WHICH INCREASES THE SUSCEPTIBILITY OF AN IMPLANT TO CORROSIVE ATTACK SUCH AS FRETTING AND/OR PITTING. POOR BONE QUALITY AND INADEQUATE BONE INGROWTH MAY CAUSE LOSS OF PROXIMAL STEM FIXATION AND IMPLANT LOOSENING. FROM THE INFORMATION PROVIDED, IT IS UNKNOWN IF ANY OF THESE CONDITIONS WERE PRESENT. THERE WAS NO INDICATION OF ANY MANUFACTURING DEVIATIONS. NO MATERIAL DEVIATIONS WERE FOUND IN THIS INVESTIGATION. CORRECTION: THE CORRECT FDA MANUFACTURING REGISTRATION SITE SHOULD BE 8010764; INSTEAD OF 1020279.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MSF FEMORAL COMPONENT MEH SMITH AND NEPHEW, GERMANY 08FTM0026A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R