BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP HIGHCROSS LINER

    MDR report key: 2328140 · Received October 26, 2011

    Report

    Report Number
    3005180920-2011-00057
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 26, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. VERSAFITCUP DOUBLE MOBILITY LINER - (B)(4) LOT 103411: (B)(4). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TWENTY TWO LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. COCR FEMORAL BALL HEAD (K072857) - (B)(4)/LOT. 111970: (B)(4). ALL PARAMETERS WERE FOUND TO BE CONFIRMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TWENTY THREE HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE DOUBLE MOBILITY LINERS HAVE A RETENSION MECHANISM WITH THE BALL HEADS AND THE HEADS ARE IMPACTED ON THE LINERS WITH A SPECIFIC INSTRUMENT. THE PIECES WERE NOT YET RECEIVED BACK FOR THE ANALYSIS. ON THE BASIS ON THE INFO COLLECTED, THE EVENT IS PROBABLY RELATED TO A WRONG OPERATION DONE DURING THE SURGERY.

    Description of Event or Problem · 1

    WHILE DOING FINAL REDUCTION OF THE HIP THE DOUBLE MOBILITY LINER DISENGAGED FROM THE 28MM COCR FEMORAL HEAD. THE SURGEON CHANGED BOTH THE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP HIGHCROSS LINER ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 103411

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT 111970| COCR FEMORAL BALL HEAD - (B)(4)