BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMF STEM RSA SIZE 5

    MDR report key: 3042749 · Received April 9, 2013

    Report

    Report Number
    1020279-2013-00201
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SMF STEM AND MODULAR NECK WERE EXAMINED VISUALLY MICROSCOPICALLY. NO DESTRUCTIVE TESTING WAS CARRIED OUT. BONE ONGROWTH WAS OBSERVED ON THE STIKTITE SURFACE OF THE SMF STEM. SCRATCHES WERE ALSO OBSERVED ON THE SMF STEM. BLACK DEBRIS WAS OBSERVED ON THE INTERNAL TAPER OF THE SMF STEM, WHICH MAY BE INDICATIVE OF A CORROSION BY-PRODUCT. THE MODULAR NECK, WHICH SEATS INTO THE STEM AT THE LOCATION WHERE DEBRIS WAS PRESENT, EXHIBITED FRETTING LINES ALONG THE TAPER. FRETTING WAS LOCALIZED TO THE NECK/STEM TAPER REGION. THE NECK/STEM TAPER REGION ON THE MODULAR NECK ALSO SHOWED SIGNS OF TI-6AL-4V METAL TRANSFER FROM THE STEM. THE EDXA SHOWED THAT THE MODULAR NECK HAD PEAKS CONSISTENT WITH COBALT CHROMIUM MOLYBDENUM WHEN COMPARED TO A STANDARD OF THE MATERIAL, BUT ALSO CONTAINED TRACES OF TI-6AL-4V DUE TO THE METAL TRANSFER. NO FRETTING WAS OBSERVED ON THE MODULAR NECK TAPER THAT CONNECTED TO THE FEMORAL HEAD. THE FEMORAL HEAD TAPER HAD STAINS ON THE TAPER THAT APPEARED LIKE BLOOD. THE FEMORAL HEAD HAD SCRATCHES ON THE CONTACT SURFACE THAT APPEARED TO OCCUR DURING USAGE. THE POLYETHYLENE LINER HAD WEAR ON THE ARTICULATING SURFACE AND NO DAMAGE WAS OBSERVED ON THE LOCKING MECHANISM. THE CAUSES FOR REVISION SURGERY CAN BE ATTRIBUTED BUT 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. THERE WAS NO INDICATION OF ANY MANUFACTURING DEVIATIONS. NO MATERIAL DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT'S COMPLAINT OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146336 SMF STEM RSA SIZE 5 HIP IMPLANT JDH SMITH & NEPHEW, INC. 08FM05350A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)