BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP ACETABULAR SHELL

    MDR report key: 1994339 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00029
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 1, 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: VERSAFIT CUP DOUBLE MOBILITY ACETABULAR SHELL - (B)(4) / LOT 101397. THE QUALITY AND MFG DOCUMENTS OF THE ACETABULAR SHELL LOT 101397 (39 PIECES PRODUCED) HAVE BEEN REVIEWED: ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THIRTY-ONE PIECES WERE IMPLANTED UP TO NOW ((B)(4)) AND ONLY THIS CASE WAS REPORTED. STATISTICS - ALL THE EVENTS INVOLVING VERSAFIT CUP 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 (B)(6). NO OTHER SURGEONS NOTIFIED THE INSTABILITY OF (B)(4) 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

    DURING THE SURGERY, DR (B)(6) REAMED THE ACETABULUM UP TO A SIZE 50. THEN HE OPENED A SIZE 50 VERSAFIT CUP AND TRIED TO IMPACT IT. HE WAS UNABLE TO GET THE CUP TO SEAT DOWN FULLY WITH A GOOD PRESS FIT. DR (B)(6) WAS FORCED TO USE HIS BACK-UP SYSTEM IN ORDER TO USE SCREWS FOR ADDED FIXATION. THE SALES REP REFERRED THAT THERE WAS A 6 MINUTES DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP ACETABULAR SHELL ACETABULAR SHELL MEH MEDACTA INTERNATIONAL, SA 101397

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention