BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEDY HIP SPACER

    MDR report key: 6028766 · Received October 13, 2016

    Report

    Report Number
    3010537287-2016-00005
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    April 11, 2016
    Report Date
    May 16, 2016
    Manufacturer
    OSTEOREMEDIES, LLC
    Product Code
    KWL
    PMA / PMN Number
    K112470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE BASED ON THE INFORMATION AVAILABLE AND THE EVALUATION OF THE X-RAY. THE EVENT APPEARS MAY BE DUE TO THE HEAD AND STEM NOT BEING PROPERLY FIXED DURING IMPLANTATION. IT IS UNKNOWN IF THE PATIENT FOLLOWED SURGEON'S INSTRUCTIONS FOR PARTIAL WEIGHT-BEARING.

    Description of Event or Problem · 1

    THE HIP SPACER HEAD FRACTURED AWAY FROM THE STEM POSTOPERATIVELY. A REVISION SURGERY WAS PERFORMED AND THE SPACER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679316 REMEDY HIP SPACER HIP SPACER, PROSTHETIC KWL OSTEOREMEDIES, LLC RHLSMD OR00333

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention