BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ANTERIOR SUMMIT STEM INSERTER

    MDR report key: 3961169 · Received July 23, 2014

    Report

    Report Number
    MW5037443
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 17, 2014
    Manufacturer
    DEPUY
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ANTERIOR SUMMIT STEM INSERTER: TIP WAS NOTED TO BE BROKEN OFF BUT WAS NOT DETECTED UNTIL AFTER THE SURGERY WAS COMPLETED AND THE INCISION WAS CLOSED. TIP OF INSERTER IS APPROX 5MM IN LENGTH. FORM SUBMITTED BY THE SALES REP. ARE AS FOLLOWS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432196 DEPUY ANTERIOR SUMMIT STEM INSERTER HIP INSTRUMENT LXH DEPUY PG1108

    Patients

    Seq Age Sex Outcome Treatment
    1