BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S FEMORAL STEM

    MDR report key: 1970164 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00019
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    August 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. QUADRA S FEMORAL STEM SIZE 7 - (B)(4)/LOT 091029. THE QUALITY AND MANUFACTURING DOCUMENTS (BATCH RECORD) WERE REVIEWED FOR THE LOT 091029 (8 PIECES PRODUCED): ALL PARAMETERS CONCERNING THE MANUFACTURING PROCESS STEPS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FIVE PIECES OF THIS LOT WERE ALREADY IMPLANTED AND NO OTHER INCIDENTS WERE REPORTED. FROM (B)(6) 2008 TO (B)(6) 2010, WE WERE INFORMED ABOUT 12 SIMILAR EVENTS OUT OF (B)(4) QUADRA SURGERIES (DATA UPDATED ON JUNE 2010). THAT MEANS THAT THE RATIO IS 0,04%. ESTIMATES RANGING OF PERIPROSTHETIC FRACTURES OF THA IS FROM 0,1% TO 2,1%. MEDACTA INTERNATIONAL SA'S RATIO IS HENCE LOWER THAN THE ONE REPORTED IN LITERATURE. THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED; THIS INJURY IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    DR (B)(6) HAD BROACHED UP TO A SIZE 7. WE THEN REDUCED THE PT AND TOOK AN X-RAY. EVERYTHING LOOKED NORMAL. HE REMOVED THE BROACH AND IMPACTED THE QUADRA 7 STEM. THE STEM WAS SITTING LOWER THAN THE BROACH. DR (B)(6) PULLED THE QUADRA OUT AND DECIDED TO PUT A CABLE AROUND THE FEMUR. HE THEN RE-IMPLANTED THE STEM AND REDUCED THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA S FEMORAL STEM FEMORAL STEM SIZE 7 STANDARD JDI MEDACTA INTERNATIONAL SA NA 091029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention