BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM HIGHCROSS ACETABULAR LINER

    MDR report key: 3350316 · Received September 6, 2013

    Report

    Report Number
    3005180920-2013-00106
    Event Type
    Injury
    Date Received
    September 6, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DM LINER - REF. (B)(4) / LOT 113816: 39 LINERS PRODUCED - 36 IMPLANTED. COCR BALL HEAD - REF. (B)(4) LOT 123110 (K072857): 40 HEADS PRODUCED - 28 IMPLANTED. VERSAFITCUP DM - REF. (B)(4) LOT 114163 (K083116): 60 SHELLS PRODUCED - 54 IMPLANTED. ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION FOR THE THREE LOTS. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442531 VERSAFITCUP DM HIGHCROSS ACETABULAR LINER ACETABULAR INSERT LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1