BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8

    MDR report key: 7121400 · Received December 15, 2017

    Report

    Report Number
    3005180920-2017-00748
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 16, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802096
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 DECEMBER 2017. LOT 061520: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2006. EXPIRATION DATE: 2011-10-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON (B)(6) 2018: THE STEM SHOWED THE COATING ABSORBED, EXCEPT FOR A SMALL AREA IN THE METAPHYSEAL PART. SCRATCHES AND SIGNS OF REMOVAL WERE NOTICED ON THE NECK; NO OTHER PARTICULAR SIGNS WERE NOTICED AND, FROM THE RECEIVED PARTS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. ON (B)(6) 2018 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: TEN YEARS AFTER PRIMARY CEMENTLESS THA THE FEMORAL STEM IS FOUND LOOSE AND REPLACED, ALONG WITH THE ACETABULAR CUP. ACCORDING TO REPORT, "A LOT OF CONNECTIVE TISSUE" WAS FOUND IN THE PROXIMAL FEMUR AREA. THIS IS ONLY PARTIALLY VISIBLE IN THE ONE XRAY SUPPLIED. THE TRIBOLOGICAL PAIRING IS CERAMIC ON CERAMIC SO IT IS UNLIKELY THAT AN OSTEOLYTIC REACTION WAS ORIGINATED BY PARTICULATE DEBRIS. NO SIGNS OF ABNORMAL WEAR HAVE BEEN DESCRIBED. THE CUP IS IMPLANTED WITH VERY LITTLE OR NO ANTEVERSION, WHICH PROBABLY CAUSED FREQUENT LOW-LOAD IMPINGEMENT BETWEEN THE FEMORAL NECK AND THE INSERT RIM (TYPICALLY, IN HIGH FLEXION PLUS ADDUCTION, SUCH AS IN LEG-CROSSING POSITION). THIS IS WITNESSED BY A SMALL ROUNDED MARK ON THE STEM NECK, EXACTLY CORRESPONDENT TO THE RIM OF THE CUP. WHILE THE AMOUNT OF WEAR INDUCED BY THIS IMPINGEMENT IS PROBABLY NEGLIGIBLE, THE TORSIONAL LOAD APPLIED TO THE STEM MAY HAVE CONTRIBUTED CAUSING THE FIBROUS TISSUE DEVELOPMENT AND THE LONG-TERM LOOSENING.

    Description of Event or Problem · 1

    9 YEARS AFTER PRIMARY REVISION SURGERY FOR STEM LOOSENING. THE SURGEON REVISED ALL THE IMPLANT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899464 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8 CEMENTLESS COATED HIP STEM JDI MEDACTA INTERNATIONAL SA 061520 07630030802096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention