BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP HIGHCROSS LINER

    MDR report key: 1994281 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00022
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 9, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW - VERSAFITCUP DOUBLE MOBILITY LINER - REF 01.26.2854MHC / LOT 092370 (B)(4): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MFG. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. COCR FEMORAL HEAD - REF 01.25.012 / LOT 102159 (B)(4): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MFG. (B)(4) BALL HEADS BELONGING TO THIS LOT HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. STATISTICS: ALL THE EVENTS INVOLVING CRCO BALL HEADS AND HC DOUBLE MOBILITY LINERS NOTIFIED AS COMPLAINTS WERE REVIEWED. (B)(4) IS THE ONLY ONE CONCERNING A DISLOCATION OF A CRCO HEAD, IN THAT CASE THE CRCO HEAD WAS COUPLED WITH A BIPOLAR HEAD AND THE ROOT CAUSE OF THE EVENT WAS NOT ATTRIBUTED TO THE PERFORMANCE OF THE IMPLANT. THIS CRCO BALL HEAD HAD THE LOT 092710, DIFFERENT THAN THE ONE HERE INVOLVED (102159). THE RETURNED HC LINER WAS ANALYZED. UPON DIMENSIONAL ANALYSIS, THE DIAMETER RELEVANT TO THE COUPLING WITH THE HEAD WAS FOUND TO BE OUT OF TOLERANCE (+0.063 MM). THIS FACT IS HIGH LIKELY DUE TO THE DEFORMATION OF THE PE LINER DURING SURGERY, IN PARTICULAR WHEN THE FEMORAL HEAD CAME OUT OF THE LINER, SINCE IT WAS REPORTED THAT THEY WERE INITIALLY ASSEMBLED CORRECTLY. ON THE BASIS OF THE INFO COLLECTED, THE EVENT IS THOUGHT TO BE NOT DEVICE RELATED, BUT PROBABLY DUE TO A WRONG ACTION DONE DURING THE SURGERY.

    Description of Event or Problem · 1

    WHEN REDUCING THE HIP, THE LINER DISENGAGED FROM THE COBALT CHROME HEAD. THE COBALT CHROME HEAD AND LINER WERE INITIALLY ASSEMBLED CORRECTLY. OPENED ANOTHER HIGH CROSS LINER AND REASSEMBLED WITH THE COBALT CHROME HEAD; IMPLANTED THE PT. THE HIP WAS THEN SUCCESSFULLY REDUCED 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 NA 092370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COCR FEMORAL BALL HEAD - REF 01.25.012 / LOT102159