BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY ACETABULAR CUP

    MDR report key: 3011005 · Received March 8, 2013

    Report

    Report Number
    3005180920-2013-00010
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    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 DM CEMENTLESS ACETABULAR CUP 60: CODE 01.26.60MB / LOT 113445 (18 CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 7 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE DATA COLLECTED, THE DISLOCATION IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4), MEDACTA INTERNATIONAL WAS INFORMED THAT THE SAME PT UNDERWENT ANOTHER REVISION SURGERY BEFORE THE ONE ALREADY REPORTED. IT WAS DISCOVERED THAT, AFTER THE PRIMARY SURGERY, THE PT GOT OUT OF BED BEFORE HE WAS SUPPOSED TO AND HE WAS REOPERATED DUE TO A DISLOCATION OF THE CUP. ACETABULAR CUP, PE LINER AND FEMORAL HAD HAVE BEEN REVISED, WHILE THE STEM HAS BEEN KEPT IN PLACE. THE FIRST REVISION HAS NOT BEEN REPORTED TO MEDACTA WHEN IT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100649 VERSAFITCUP DOUBLE MOBILITY ACETABULAR CUP ACETABULAR CEMENTLESS CUP 60 LZO MEDACTA INTERNATIONAL SA 113445

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DOUBLE MOBILITY LINER CODE 01.26.2860MHC| COCR FEMORAL HEAD 28 S CODE 01.25.011| LOT 114205, K092265| LOT 122443 , K072857