BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATH THREAD CUP ADAPTOR

    MDR report key: 9940894 · Received April 8, 2020

    Report

    Report Number
    3010536692-2020-00333
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 13, 2020
    Report Date
    June 30, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LXH
    UDI-DI
    M684200700131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY, THIS IS AN INSTRUMENT, THREAD DEBRIS WHERE LEFT IN THE PATIENT. THREADS FOUND POST OP ON X-RAY AND LEFT IN PATIENT. THE PHYSICIAN WAS NOT AWARE THE THAT THE INSTRUMENT HAD BROKEN UNTIL X-RAY WAS READ IN POST OP. THREADS BROKEN ON INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400379 PATH THREAD CUP ADAPTOR HIP INSTRUMENT LXH MICROPORT ORTHOPEDICS INC. 20070013 NI M684200700131

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other