BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR SHELL

    MDR report key: 2861809 · Received November 29, 2012

    Report

    Report Number
    3005180920-2012-00080
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 11, 2012
    Report Date
    November 29, 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 113302 ((B)(4) SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE PROBLEM OCCURRED IS HIGHLY LIKELY DUE TO A SURGICAL MISTAKE DURING THE REAMING PHASE AND NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE SHELL SIZE 52 WAS IMPLANTED BUT WOULD NOT HOLD ITS POSITION, IT WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT. 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 113302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention