BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM SIZE 3 STD

    MDR report key: 2858773 · Received November 26, 2012

    Report

    Report Number
    3005180920-2012-00077
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 STD - REF. 01.12.023/ LOT 121504 (60 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 ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. TWENTY-EIGHT STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THERE IS NO EVIDENCE THAT THE EVENT IS DEVICE RELATED: THE LEG LENGTH DISCREPANCY IMMEDIATELY DETECTED POST OP IS PROBABLY DUE TO A WRONG EVALUATION OF THE IMPLANTS SIZE.

    Description of Event or Problem · 1

    WHEN PATIENT WAS REMOVED FROM THE OPERATING TABLE, THE SURGEON NOTED THAT THE LEG THAT WAS OPERATED ON WAS APPROXIMATELY 1 CM LONGER THAN THE CONTRALATERAL LEG. REVISION SURGERY WAS SUCCESSFULLY COMPLETED VIA AN ANTERIOR APPROACH. DURING ATTEMPT TO REMOVE THE FEMORAL HEAD THE STEM SHOWED SIGNS OF MOVING, SO THE SURGEON REMOVED BOTH ITEMS AND IMPLANTED A QUADRA-H SHORT NECK STEM AND 28MM M HEAD TO CORRECT LEG LENGTH. WE WERE INFORMED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H CEMENTLESS STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL, SA 121504

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NOT MARKETED IN THE USA.| BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L