BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY LINER

    MDR report key: 1970165 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00020
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    August 25, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - REF (B)(4)/LOT 092012. VERSAFITCUP DOUBLE MOBILITY LINER - REF (B)(4)/LOT 090897. DOCUMENT REVIEW OF THE TWO LOTS MANUFACTURED BY MEDACTA WAS CARRIED OUT: ALL THE VALUES WERE FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS IN FORCE AT THE TIME OF PRODUCTION. NINETEEN SHELLS OF THE LOT 092012 (B)(4) WERE ALREADY IMPLANTED. FIFTY FIVE LINERS OF THE LOT 090897 (B)(4) WERE ALREADY IMPLANTED. NO SIMILAR EVENTS WERE REPORTED, INVOLVING THE IMPLANTS OF THESE TWO LOTS. IN THE PACKAGE INSERTS (IFU) CONTAINED IN THE BOXES OF THE TWO IMPLANTS MANUFACTURED BY MEDACTA INTERNATIONAL AND INVOLVED IN THIS COMPLAINT IS CLEARLY WRITTEN: "MEDACTA INTERNATIONAL IS NOT RESPONSIBLE FOR THE USE OF ITS IMPLANT COMMENTS IN COMBINATION WITH A COMPONENT FROM ANOTHER MANUFACTURER (UNLESS OTHERWISE SPECIFIED BY MEDACTA INTERNATIONAL IN THE SURGICAL TECHNIQUE), THEREFORE, WE ADVISE AGAINST SUCH A USE". AND IN THE SURGICAL TECHNIQUES THERE IS NOT ANY INDICATION CONCERNING THE FEMORAL HEAD "OXINIUM" USED BY THE SURGEON AND MEDACTA HAS NEVER SOLD OR SUGGESTED TO USE THESE BALL HEADS IN COMBINATION WITH ITS IMPLANTS. FROM THE INFO COLLECTED SO FAR, THERE IS NO EVIDENCE THAT THE EVENT COULD BE RELATED TO A DEVICE MARKETED BY MEDACTA INTERNATIONAL.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED ON (B)(6), 2010. THE IMPLANTS INVOLVED ARE A VERSAFITCUP DOUBLE MOBILITY LINER MICRON 48/28 ((B)(4), LOT 090897) AND AN ACETABULAR SHELL MICRON 48 (REF (B)(4), LOT 092012). REVISION SURGERY, DUE TO THE DISLOCATION OF THE FEMORAL HEAD OXINIUM (CE MARKED BY SMITH AND NEPHEW) FROM THE DOUBLE MOBILITY LINER VERSAFITCUP, WAS PERFORMED. IT WAS REPORTED THAT THE PT SOUNDED MECHANICAL NOISE AND FELT PAIN. THE DISLOCATION WAS CONFIRMED WITH X-RAYS. THE FRICTION BETWEEN THE HEAD AND THE CUP CAUSED METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DOUBLE MOBILITY LINER ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 090897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL -| REF (B)(4)/LOT 092012