BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø52

    MDR report key: 5916987 · Received August 31, 2016

    Report

    Report Number
    3005180920-2016-00443
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 2, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 SEPTEMBER 2016 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SIGNIFICANT MEDIAL MIGRATION OF A DOUBLE MOBILITY CEMENTLESS CUP IN THA AFTER 7 YEARS. THE REASONS FOR MIGRATION CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE CUP LOOKS SLIGHTLY OVERSIZED, BUT THIS IS UNLIKELY TO HAVE BEEN THE MAIN CAUSE FOR THE PROBLEM. CUP MIGRATION IS A POSSIBLE ADVERSE EVENT FOLLOWING THA. THERE ARE NO ELEMENTS TO SUGGEST THAT A FAULTY DEVICE CAUSED THIS PROBLEM.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 AUGUST 2016. LOT 090243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 APRIL 2009. EXPIRATION DATE: 2014-03-31. 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 COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THAT THE CUP HAD LOOSENED. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569861 VERSAFITCUP ACETABULAR SHELL Ø52 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 090243

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention