BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP REVISION GENERAL INSTRUMENT RADIAL BLADE L=127X10 MM SLOT

    MDR report key: 8722203 · Received June 21, 2019

    Report

    Report Number
    3005180920-2019-00498
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 21, 2019
    Manufacturer
    HPF SPA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: AFTER HAVING SEEN THE IMAGE RECEIVED AND AFTER HAVING MADE THE VISUAL INSPECTION ON 19TH JUNE 2019, I CAME TO THE FOLLOWING CONSIDERATIONS: THE BLADE WAS BROKEN AT THE TIP NEAR THE CHAMFERED EDGE; THE ROOT CAUSE IS DIFFICULT TO UNDERSTAND. THIS MAY BE DUE TO IMPROPER USE OR AN INCORRECT PRODUCTION PROCESS.

    Description of Event or Problem · 1

    WHILE EXPLANTING THE FEMORAL STEM, THE CURVED OSTEOTOME BROKE WHEN USED AROUND THE SHOULDER OF THE IMPLANT. NO INSTRUMENT FRAGMENT REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514926 HIP REVISION GENERAL INSTRUMENT RADIAL BLADE L=127X10 MM SLOT SURGICAL INSUTRMENT FOR HIP SURGERY LXH HPF SPA 15H4062

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other