BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSITU HIP SYSTEM

    MDR report key: 7558492 · Received May 31, 2018

    Report

    Report Number
    3002498892-2018-00009
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    April 5, 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

    ADVERSE EVENT NOT RELATED TO PRODUCT MALFUNCTION. POST OP FEMUR FRACTURE IS MULTIFACTORIAL, INCLUDING BUT NOT LIMITED TO, TRAUMA, SURGICAL TECHNIQUE, PATIENT COMPLIANCE, AND BONE QUALITY. ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    SURGEON HAD A FRACTURED FEMUR COME TO HIS ATTENTION POST-OP. HE CHOOSE TO THEN REVIS THE PATIENT. REMOVED FEMORAL STEM AND HEAD. CUP AND LINERS WERE NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398158 INSITU HIP SYSTEM TOTAL HIP REPLACEMENT SYSTEM LPH THEKEN COMPANIES LLC 10-10-0006 1076B 00816127021992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention