BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC HC LINER 32 E

    MDR report key: 3533167 · Received December 13, 2013

    Report

    Report Number
    3005180920-2013-00164
    Event Type
    Injury
    Date Received
    December 13, 2013
    Date of Event
    November 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC HC PE LINER: REF. (B)(4) / LOT 132329 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 LAT (K082792): REF. (B)(4) / LOT 122033 ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. COCR FEMORAL HEAD 32 M (K072857): REF. (B)(4) / LOT 132890 ((B)(4) HEADS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC TRIO NO HOLES SHELL (K122911): REF. (B)(4) / LOT 125751 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. FIFTY FIVE HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE 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
    653071 VERSAFITCUP CC HC LINER 32 E ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL, SA 132329

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention