BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER Ø 58/28

    MDR report key: 6263416 · Received January 19, 2017

    Report

    Report Number
    3005180920-2016-00749
    Event Type
    Injury
    Date Received
    January 19, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 19, 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 05 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: POSTOPERATIVE INFECTION OCCURRED 3 WEEKS AFTER SURGERY. INFECTION IS A KNOWN ADVERSE EVENT THAT MAY FOLLOW SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 17 JANUARY 2017. LOT 160076: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MARCH 2016. EXPIRATION DATE: 2021-03-09. 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.

    Description of Event or Problem · 1

    INFECTION DEVELOPED POST SURGERY. THE SURGEON REPLACED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47059 DOUBLE MOBILITY HC LINER Ø 58/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 160076

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention