BEUDAMED
    FDA Adverse Event Death Summary report: N

    OSSURE LOEP KIT

    MDR report key: 8200086 · Received December 27, 2018

    Report

    Report Number
    3011662387-2018-00001
    Event Type
    Death
    Date Received
    December 27, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 28, 2018
    Manufacturer
    AGNOVOS HEALTHCARE USA, LLC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OSSURE LOEP KIT IS NOT MARKETED IN THE UNITED STATES, AND IT IS ONLY EXPORTED FROM THE USA. THE IMPLANT MATERIAL IN THE OSSURE LOEP KIT IS EQUIVALENT TO THE IMPLANT MATERIAL IDENTIFIED IN 510(K)# K181342.

    Description of Event or Problem · 1

    PATIENT UNDERWENT CEMENTED HEMI-ARTHROPLASTY FOR HIP FRACTURE REPAIR AND INJECTION OF IMPLANT MATERIAL IN CONTRALATERAL HIP. PATIENT HAD CARDIAC ARREST AFTER WOUND CLOSURE AND DID NOT RESUSCITATE. SURGEON REPORTED TO AGNOVOS THAT THE DEATH WAS NOT RELATED TO OSSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038372 OSSURE LOEP KIT SYNTHETIC BONE GRAFT SUBSTITUTE MQV AGNOVOS HEALTHCARE USA, LLC 170901-01

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death ANTIOBIOTIC-LOADED BONE CEMENT| COCRMO HIP PROSTHESIS