BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP ACETABULAR SHELL

    MDR report key: 1994340 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00024
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    October 4, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - REF 01.26.52MB / LOT 101399 QUALITY AND MFG DOCUMENTS WERE REVIEWED FOR THE LOT 101399 (B)(4): ALL PARAMETERS RELATED TO THE EXTERNAL DIAMETER WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(4) PIECES WERE IMPLANTED UP TO NOW (14 IN THE USA) AND ONLY THIS CASE WAS REPORTED. STATISTICS - ALL THE EVENTS INVOLVING VERSAFITCUP ACETABULAR SHELL NOTIFIED AS COMPLAINTS WERE REVIEWED. THE FAILURE TO PRESS FIT OCCURRED THREE TIMES IN 2010, (B)(4), NO SIMILAR EVENTS ON THE SAME ISSUE WERE REPORTED IN THE PAST. THE THREE EVENTS INVOLVE THREE DIFFERENT LOTS OF ACETABULAR SHELLS AND THE PROBLEM OCCURRED TWICE TO DR (B)(6) AND ONCE TO DOCTOR (B)(6), BOTH IN THE USA. NO OTHER SURGEONS NOTIFIED THE INSTABILITY OF MEDACTA'S METAL BACKS SO FAR. FOR THIS REASON, THE FAILURE TO PRESS FIT IS LIKELY TO BE ASSOCIATED WITH THE REAMING TECHNIQUES AND THE EVENT IS THOUGHT TO BE NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE ACETABULAR SHELL CAME OUT DURING HIP REDUCTION. THE SURGEON HAS NOTICED THAT THE COMPONENT WAS NOT STABLE AFTER IMPLANTATION. A SCREW HOLED CUP WAS IMPLANTED AND THE SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP ACETABULAR SHELL ACETABULAR SHELL MEH MEDACTA INTERNATIONAL, SA 101399

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention