BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM CUP 54

    MDR report key: 3233298 · Received July 12, 2013

    Report

    Report Number
    3005180920-2013-00081
    Event Type
    Injury
    Date Received
    July 12, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DM CUP CODE (B)(4), LOT 125338 (50 ITEMS PRODUCED, 26 IMPLANTED UP TO NOW). VERSAFITCUP DM HC LINER CODE (B)(4), LOT 125360: (30 ITEMS PRODUCED, 12 IMPLANTED UP TO NOW). MECTACER DELTA BALL HEAD CODE (B)(4), LOT 124371 (70 ITEMS PRODUCED, 48 IMPLANTED UP TO NOW."AMISTEM H CEMENTLESS STEM CODE (B)(4), LOT 130048 (69 ITEMS PRODUCED, 34 IMPLANTED UP TO NOW). ALL PARAMETERS OF THE FOUR LOTS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLES WERE FUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATIONS. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF. IMP #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324730 VERSAFITCUP DM CUP 54 ACETABULAR SHELL CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1