BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMG

    MDR report key: 6445970 · Received March 30, 2017

    Report

    Report Number
    3005180920-2017-00143
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 30, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 17 MARCH 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ONE MONTH AFTER PRIMARY SURGERY, THE PATIENT WAS COMPLAINING ABOUT PAIN. ACCORDING TO THE REPORT, THE DOUBLE MOBILITY LINER WAS EXCHANGED DUE TO THE PRESENCE OF A HEMATOMA. THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 27 MARCH 2017. LOT 160253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2016. EXPIRATION DATE: 2021-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 30 MARCH 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION AND COMMENTED AS FOLLOWS: THE PIECES WERE ANALYZED. SOME SIGNS WERE NOTICED ON THE SURFACE OF THE PE DM LINER AND SOME DARK SIGNS WERE NOTICED ON THE RIM OF THE CERAMIC BALL HEAD, PROBABLY OCCURRED DURING THE REVISION SURGERY. FROM THE RECEIVED PIECES IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT BUT THERE IS NO REASON TO SUSPECT A FAILURE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT HAD A HEMATOMA. THE SURGEON PERFORMED AN I & D AND SWAPPED HE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228132 DOUBLE MOBILITY HC LINER 28/DMG DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 160253

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention