BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR SHELL

    MDR report key: 2877371 · Received December 14, 2012

    Report

    Report Number
    3005180920-2012-00088
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - (B)(4) / LOT 111516 (45 SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. THIRTY-SIX CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. IT WAS REPORTED THAT THE ACETABULAR CUP WAS TOO LARGE AND REAMING WAS INSUFFICIENT AND THAT MACRO STRUCTURES WERE OUTSIDE THE ACETABULUM. FROM THE DATA COLLECTED, THE PROBLEM OCCURRED IS HIGHLY LIKELY DUE TO A SURGICAL MISTAKE OR A WRONG SURGICAL PLAN AND NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO PT PAIN 1 MONTH POST OP. WE WERE INFORMED ON (B)(6) 2012 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DM ACETABULAR SHELL ACETABULAR DOUBLE MOBILITY SHELL MEH MEDACTA INTERNATIONAL, SA 111516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention