BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 2941611 · Received January 7, 2013

    Report

    Report Number
    3005180920-2012-00098
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 24, 2012
    Report Date
    January 7, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 6 STD - REF. 01.12.026 / LOT 082944 (32 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARMS OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE 24 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. CERAMIC FEMORAL HEAD MANUFACTURED BY(B)(4) AND ONLY DISTRIBUTED BY MEDACTA: WE BOUGHT 98 HEADS OF THE LOT INVOLVED. THE 80 HEADS HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR CASE. VERSAFITCUP CC HIGHCROSS PE LINER (K103352): REF. 01.26.364HCT - LOT 082309 (31 INSERTS PRODUCED): NO ANOMALIES FOUND IN THE DOCUMENT REVIEW, AS FOR THE STEM. THE 29 LINERS OF THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC LIGHT SHELL - NOT MARKETED IN THE USA - LOT 082891 (20 CUPS PRODUCED): NO ANOMALIES FOUND IN THE DOCUMENT REVIEW, AS FOR THE STEM. THE 19 CUPS OF THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE IS NO EVIDENCE THAT THE INFECTION OCCURRED IS DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 3 YEARS POST OP. ALL THE COMPONENTS REVISED. WE WERE INFORMED ON (B)(6) 2012 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7538 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 6 STD CEMENTLESS JDI MEDACTA INTERNATIONAL SA 082944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IN USA. HX PE LINER CODE 01.26.3648HCT LOT 082309| (K103352)| CERAMIC BALL HEAD ANDACETABULAR CUP NOT MARKETED