BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 52/28

    MDR report key: 6621622 · Received June 8, 2017

    Report

    Report Number
    3005180920-2017-00287
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 9, 2017
    Report Date
    June 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 JUNE 2017. LOT 162102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JULY 2016. EXPIRATION DATE: 2021-06-13. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE MEDACTA LINER AND THE OTHER COMPANY'S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407961 VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 52/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 162102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention