BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC LINER

    MDR report key: 4206333 · Received October 23, 2014

    Report

    Report Number
    3005180920-2014-00138
    Event Type
    Injury
    Date Received
    October 23, 2014
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC HIGHCROSS PE LINER; REF 01.26.3244HCT/LOT #: 141707 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. CERAMIC FEMORAL HEAD NOT MARKETED IN THE USA: (B)(4) HEAD BOUGHT AND ALL IMPLANTED. 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
    677413 VERSAFITCUP CC LINER ACETABULAR PE LINER LZO

    Patients

    Seq Age Sex Outcome Treatment
    1