BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL 58

    MDR report key: 3080668 · Received April 8, 2013

    Report

    Report Number
    3005180920-2013-00031
    Event Type
    Injury
    Date Received
    April 8, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO CEMENTLESS SHELL 58 - REF (B)(4)/ LOT 111806 (B)(4) ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE AND THE STERILIZATION CYCLE HAVE BEEN PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. (B)(4). VERSAFITCUP CC HC PE LINER - REF (B)(4)/ LOT 104598 (B)(4) ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE AND THE STERILIZATION CYCLE HAVE BEEN PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. (B)(4). QUADRA H CEMENTLESS FEMORAL STEM SIZE 4 LAT (K082792) - REF (B)(4)/ LOT 100018 (B)(4) ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE AND THE STERILIZATION CYCLE HAVE BEEN PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. (B)(4). FROM THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE INFECTION IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144533 VERSAFITCUP CC TRIO ACETABULAR SHELL 58 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1