BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004371426-2018-00016

    MDR report key: 8100937 · Received November 26, 2018

    Report

    Report Number
    3004371426-2018-00016
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 9, 2018
    PMA / PMN Number
    K142187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE SMALLEST AVAILABLE STEM SIZE (ART. NO. 172-916/12) THE REAMING GUIDE AND THE GUIDE ROD CAN'T BE SCREWED INTO THE INTENDED DEPTH. THE REASON FOR THIS IS A REDUCED DEPTH OF THE CORE HOLE IN THE STEM. A REAMING GUIDE THAT IS NOT SCREWED IN COMPLETELY MAY LEAD TO A PROXIMAL PREPARATION IN THE DEPTH THAT IS NOT SUFFICIENT AND TO A NECK THAT CAN'T BE POSITIONED CORRECTLY. CORRECTIVE REAMING CAN LEAD TO A SURGERY TIME EXTENSION. THE CORRECT FIT OF THE NECK CAN'T BE VERIFIED BY MEANS OF THE GUIDE ROD. THIS FAILURE CAN ONLY OCCUR WITH THE SMALLEST AVAILABLE STEM SIZE (ART. NO. 172-916/12). INITIATION OF THE CORRECTIVE AND PREVENTIVE ACTION: CAPA-(B)(4).

    Description of Event or Problem · 1

    TRANSLATION: DURING THE SURGERY OF 160/12 MP HIP STEM, BOTH REAMING GUIDES AND THE GUIDE ROD COULD NOT BE SCREWED INTO THE TRIAL STEM OR THE ORIGINAL STEM UNTIL THE REQUIRED FINAL POSITION WAS REACHED. ON THE ONE HAND, THIS RESULTS IN AN INCOMPLETE METAPHYSEAL REAMING OF THE NECK PART, ON THE OTHER HAND, THE CORRECT SEATING OF THE NECK CAN NOT BE CONTROLLED WITH THE GUIDE ROD . IN SITU, UNFORTUNATELY, NO USABLE PHOTOS COULD BE TAKEN WITH THE ORIGINAL STEM. USEFUL PHOTOS WITH THE TRIAL STEM ON THE STERILIZING TABLE ARE INCLUDED IN THE ATTACHMENT. THERE YOU CAN SEE THAT THE TIP OF THE REAMING GUIDE IN THE DEPTH CONTACTS THE BOTTOM OF THE THREADED HOLE OF THE TRIAL STEM. FOR ALL OTHER STEM SIZES THE REAMING GUIDE AND THE GUIDE ROD CAN BE SCREWED IN CORRECTLY TO THE FINAL POSITION. (LINK REPRESENTATIVE (B)(6)).

    Patients

    Seq Age Sex Outcome Treatment
    1