BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL HIP G2

    MDR report key: 11979298 · Received June 10, 2021

    Report

    Report Number
    3004153240-2021-00086
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 10, 2021
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LPH
    UDI-DI
    M572HAA050D001021
    PMA / PMN Number
    K192198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TRIAL NECK BROKE OFF DURING WHILE TESTING THE PATIENT'S RANGE OF MOTION. THE SURGEON MOVED FORWARD WITH THE PROCEDURE USING THE IMPLANT AND TRIAL HEAD. THERE WAS NEITHER PATIENT IMPACT AS A RESULT OF THIS INCIDENT NOR WAS THERE ANY MAJOR DELAY IN SURGERY. THE DELAY IN SURGERY WAS ONLY A MINUTE OR TWO. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIAL NECK BROKE OFF DURING WHILE TESTING THE PATIENT'S RANGE OF MOTION. THE SURGEON MOVED FORWARD WITH THE PROCEDURE USING THE IMPLANT AND TRIAL HEAD. THERE WAS NEITHER PATIENT IMPACT AS A RESULT OF THIS INCIDENT NOR WAS THERE ANY MAJOR DELAY IN SURGERY. THE DELAY IN SURGERY WAS ONLY A MINUTE OR TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876749 ITOTAL HIP G2 HIP REPLACEMENT SYSTEM LPH CONFORMIS, INC. M572HAA050D001021

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR