BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSITU HIP REPLACEMENT SYSTEM

    MDR report key: 8191533 · Received December 21, 2018

    Report

    Report Number
    3002498892-2018-00017
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 21, 2018
    Manufacturer
    THEKEN COMPANIES, LLC
    Product Code
    LPH
    PMA / PMN Number
    K161184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAUSE OF DISLOCATION IS NOT KNOWN. NO PRODUCT MALFUNCTION REPORTED. NO PREVIOUS INCIDENTS OF SAME NATURE. NO PRODUCT NON-CONFORMANCE RECORDED IN HOUSE. POTENTIAL CAUSE IS BONE POOR QUALITY, IMPROPER SIZE IMPLANTS OR OTHER. THIS EVENT IS NOT RELATED TO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT DISLOCATED PREVIOUSLY IMPLANTED HIP SYSTEM. SURGEON REMOVED HEAD AND NEUTRAL LINER. INSERTED A FACE CHANGING LINER AND NEW HEAD. PATIENT STABLE AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029099 INSITU HIP REPLACEMENT SYSTEM TOTAL HIP REPLACEMENT SYSTEM LPH THEKEN COMPANIES, LLC 10-40-3650 1057-1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention