BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCOX TOTAL HIP SYSTEM INSTRUMENT HEAD TRIAL

    MDR report key: 7863458 · Received September 11, 2018

    Report

    Report Number
    3009106092-2018-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 10, 2018
    Manufacturer
    CORENTEC CO., LTD.
    Product Code
    KWY
    UDI-DI
    08806373879043
    PMA / PMN Number
    K103431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE WAS DELAYED DUE TO TRIAL HEAD BECOMING STUCK, BUT TRIAL HEAD WAS ULTIMATELY SUCCESSFULLY REMOVED. TRUNNION OF STEM IMPLANT COULD HAVE BEEN POTENTIALLY SCRATCHED. DEVICE HISTORY RECORDS (DHRS) FOR THE DEVICE AND CONCOMITANT PRODUCTS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. SINCE THE SIMILAR CASE WITH THE REPORTED EVENT WAS NOT FOUND DURING CUSTOMER COMPLAINTS HISTORY REVIEW, IT'S HARD TO DEFINE THE ROOT CAUSE CURRENTLY AND MONITORING THE TRENDS IS REQUIRED. ONCE ANY SUPPLEMENTAL INFORMATION IS FOUND WHICH WOULD CHANGE ANY INFORMATION OR CONCLUSIONS, ADDITIONAL INFORMATION WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    A PORTION OF THE METAL LOCKING RING INSIDE THE TRIAL HEAD WAS PROTRUDING OUT WHICH CAUSED THE TRIAL TO BECOME STUCK ON THE STEM TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708303 BENCOX TOTAL HIP SYSTEM INSTRUMENT HEAD TRIAL PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY CORENTEC CO., LTD. HA.02I.0361 30AGAKJ2001 08806373879043

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR