BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL HIP G2

    MDR report key: 11802851 · Received May 10, 2021

    Report

    Report Number
    3004153240-2021-00069
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 10, 2021
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LPH
    UDI-DI
    M572HBS0330000011
    PMA / PMN Number
    K192198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SURGEON HAD TROUBLES WITH THE FIT AND POSITIONING OF THE PATIENT-SPECIFIC STEM. THE SURGEON WAS UNABLE TO FULLY SEAT THE SIZE 13 STEM WHICH SAT 10 MM PROUD. HE COMPLETED THE SURGERY WITH A SMALLER STEM FROM ANOTHER VENDOR WHILE STILL UTILIZING THE CONFORMIS CUP, LINER, AND HEAD. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE SURGEON FOR CASE DID NOT UTILIZE THE PATIENT-SPECIFIC F2 JIG PROVIDED WITH THE IMPLANT SYSTEM. FAILURE TO UTILIZE THE F2 JIG CAN LEAD TO IMPROPER BROACH POSITIONING WHICH WILL CAUSE THE STEM TO SIT PROUD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD TROUBLES WITH THE FIT AND POSITIONING OF THE PATIENT-SPECIFIC STEM. THE SURGEON WAS UNABLE TO FULLY SEAT THE SIZE 13 STEM WHICH SAT 10 MM PROUD. HE COMPLETED THE SURGERY WITH A SMALLER STEM FROM ANOTHER VENDOR WHILE STILL UTILIZING THE CONFORMIS CUP, LINER, AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700003 ITOTAL HIP G2 HIP REPLACEMENT SYSTEM LPH CONFORMIS, INC. HBS033000001 M572HBS0330000011

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention