BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC LINER

    MDR report key: 4345592 · Received December 12, 2014

    Report

    Report Number
    3005180920-2014-00187
    Event Type
    Injury
    Date Received
    December 12, 2014
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K120531
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC HIGHCROSS PE LINER: (B)(4) / LOT 144764 ((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. TOTAL OF (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC HIGHCROSS PE LINER: REF (B)(4) / LOT 142640 ((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. TOTAL OF (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC HIGHCROSS PE LINER: (B)(4) / LOT 142640 ((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. TOTAL OF (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC TRIO NO HOLES SHELL (K122911): (B)(4) / LOT 144704 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. TOTAL OF (B)(4) SHELLS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    THE DESCRIPTION OF THE EVENT IN THE INITIAL REPORT WAS NOT CLEAR. HERE IS A BETTER CLARIFICATION: DURING THE SURGERY, THE SURGEON TRIED TO IMPLANT THE LINER BUT IT WAS NOT POSSIBLE TO IMPACT IT CORRECTLY IN THE SHELL. HE TRIED WITH A SECOND LINER, HAVING THE SAME PROBLEM. THE SURGERY WAS FINALLY COMPLETED CHANGING THE SHELL AND USING A NEW LINER, THAT WAS CORRECTLY COUPLED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808115 VERSAFITCUP CC LINER ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK