BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSITU HIP SYSTEM

    MDR report key: 7558513 · Received May 31, 2018

    Report

    Report Number
    3002498892-2018-00010
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 31, 2018
    Manufacturer
    THEKEN COMPANIES LLC
    Product Code
    LPH
    UDI-DI
    00816127021992
    PMA / PMN Number
    K161184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERIPROSTHETIC FRACTURE IS MULTIFACTORIAL, INCLUDING BUT NOT LIMITED TO, TRAUMA , SURGICAL TECHNIQUE, PATIENT COMPLIANCE, AND BONE QUALITY. BONE FRACTURE CANNOT BE ATTRIBUTED TI DESIGN MALFUNCTION, BASED ON THE DETAILS PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. ADVERSE EVENT IS NOT RELATED TO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT HEARD A POP AND FEW DAYS LATER REPORTED TO CLINIC WITH DISCOMFORT. SURGEON DETERMINED THAT THERE WAS A FRACTURE. THE FEMORAL HEAD AND STEM WERE REMOVED. AFTER GOING TO REHAB FACILITY PATIENT FELL AND WAS FOUND ON FLOOR BY STAFF. A LONGER STEM AND NEW FEMORAL HEAD WERE THEN IMPLANTED ALONG WITH CABLES THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398172 INSITU HIP SYSTEM TOTAL HIP REPLACEMENT SYSTEM LPH THEKEN COMPANIES LLC 10-10-0006 1076B 00816127021992

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention