BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28

    MDR report key: 6947206 · Received October 13, 2017

    Report

    Report Number
    3005180920-2017-00584
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    October 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807442
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 162327: 100 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 62 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE HIP AND LEFT ALL IMPLANTS IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728442 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 162327 07630030807442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention