BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM SHELL 50

    MDR report key: 4878380 · Received June 26, 2015

    Report

    Report Number
    3005180920-2015-00129
    Event Type
    Injury
    Date Received
    June 26, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JUNE 2015: LOT 090242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAY 2009. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 03 JUNE 2015 THE (B)(4) MADE THE FOLLOWING COMMENT: ONLY A POOR QUALITY PRE-REVISION XRAY AND NO EXPLANATIONS ARE AVAILABLE. FROM SUCH DATA, IDENTIFICATION OF ROOT CAUSE FOR CUP LOOSENING IS IMPOSSIBLE. THE XRAY DOES NOT SUGGEST ANY EVIDENT REASON FOR FAILURE.

    Additional Manufacturer Narrative · 1

    ON 21 AUGUST IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY REPORTED INTO THE INITIAL MDR. ON THE SAME DATE IT WAS SENT TO THE INTIAL REPORTED AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415639 VERSAFITCUP DM SHELL 50 CEMENTLESS ACETABULAR SHELL MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1