BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR CUP 50

    MDR report key: 4195551 · Received September 12, 2014

    Report

    Report Number
    3005180920-2014-00122
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 12, 2014
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DM ACETABULAR SHELL 50, CODE 01.26.50MB - LOT 090242 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE PROBLEM IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565438 VERSAFITCUP DM ACETABULAR CUP 50 DOUBLE MOBILITY ACETABULAR SHELL MEH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention