BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1

    MDR report key: 9971095 · Received April 17, 2020

    Report

    Report Number
    3005180920-2020-00248
    Event Type
    Injury
    Date Received
    April 17, 2020
    Date of Event
    March 18, 2020
    Report Date
    April 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 MARCH 2020: LOT 181751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2018. EXPIRATION DATE: 2023-06-19. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 11 MONTHS AFTER PRIMARY CEMENTLESS THA THE STEM IS REVISED. THE PATIENT SUFFERED A GREATER TROCHANTER FRACTURE, WHICH REQUIRED CERCLAGE, BUT THIS MOST PROBABLY CAUSED THE STEM TO SUBSIDE VERY SIGNIFICANTLY AND LOOSE PRESS FIT AND STABILITY. ALSO, PROBABLY DUE TO BONE REMODELLING AFTER FRACTURE HEALING, THE STEM FINALLY LOOKS UNDERSIZED FOR THE "NEW" FEMORAL SHAPE. THE CAUSE OF THIS REVISION SHOULD NOT BE ASCRIBED TO A DEFECTIVE IMPLANT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. IMPLANT COVERED IN BIO FLUIDS.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 11 MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. AS PER THE POSTOPERATORY XRAYS OF THE PRIMARY SURGERY THE PATIENT HAD A FRACTURE OF THE GREATER TROCHANTER OF THE RIGHT FEMUR, FOR THAT REASON THE SURGEON USED A CERCLAGE WITH WIRE. AND MAYBE, THIS FRACTURE WOULD BE A REASON OF THE LOOSENING OF THE STEM. ABOUT THE REVISION SURGERY: INTRAOPERATIVELY, THE QUADRA H STEM STD SIZE 1 WAS WITHDRAWN, THE STEM WAS TOTALLY LOOSENED AND WITHOUT HYDROXYAPATITE, THE FRACTURE OF THE GREATER TROCHANTER WAS CONSOLIDATED, THE CERCLAGE WAS WITHDRAWN, THE FEMORAL CANAL WAS WASHED THOROUGHLY, A REVISION STEM OF ANOTHER COMPANY WAS IMPLANTED AND THE MEDACTA FEMORAL HEAD WAS CHANGED FROM A COCR 32 XL +7 BY A COCR 32 L +3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435056 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1 CEMETLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.021 181751 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention