BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 2669164 · Received July 12, 2012

    Report

    Report Number
    3005180920-2012-00033
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    June 14, 2012
    Report Date
    July 12, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H FEMORAL STEM SIZE 5 STD - (B)(4) / LOT 090632 (60 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING 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. THIRTY FOUR STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE RETRIEVED STEM AND THE X-RAYS WERE ANALYZED AND THE MAIN FINDINGS OF THE INVESTIGATION ARE: THE STEM WAS POSITIONED CORRECTLY AND THE RIGHT SIZE WAS USED. THE STEM WAS LOOSE PROXIMALLY. THE CAUSE OF THE LACK OF FIXATION IN THE PROXIMAL PART CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. MEDACTA CONTACTED ALSO AN EXTERNAL PHYSICIAN CONSULTANT WHO HYPOTHESIZED THAT THE CAUSE COULD BE A POSSIBLE LOW GRADE OF INFECTION. SO FAR WE DID NOT RECEIVE ANY FEEDBACK THAT CAN CONFIRM THIS HYPOTHESIS. LOOSENING IS A KNOWN COMPLICATION OF TOTAL HIP REPLACEMENTS AND, ON THE BASIS OF THE INFORMATION COLLECTED, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    REVISION OF THE STEM 18 MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 5 STANDARD JDI MEDACTA INTERNATIONAL SA 090632

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention