BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE5

    MDR report key: 8184593 · Received December 20, 2018

    Report

    Report Number
    3005180920-2018-01018
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 22, 2018
    Report Date
    December 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 DECEMBER 2018: LOT 180763: (B)(4). EXPIRATION DATE: 2023-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). CLINICAL EVALUATION PERFOREMED BY MEDICAL AFFAIRS MANAGER: POSTOPERATIVE FEMORAL FRACTURE OCCURRED FEW DAYS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. IMMEDIATE POSTOPERATIVE FRACTURES MAY OCCUR DURING THE REHABILITATION PERIOD WHEN SUDDEN MOVEMENTS, SUCH AS THE TORSIONAL MOVEMENT DESCRIBED IN THE REPORT, ON A WEAKENED BONE DUE TO INTRAOPERATIVE FEMORAL PREPARATION MAY CAUSE FEMORAL FRACTURES. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HAD A PERIPROSTHETIC FRACTURE IN THEIR FEMUR 1 WEEK AFTER THE PRIMARY, DUE TO PIVOTING ON THE LEG. THE STEM WAS REMOVED (AMIS STANDARD SIZE 5), THE FEMUR WAS CABLED AND A QUADRA STANDARD SIZE 4 WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023182 STEM: AMISTEM H HA COATED STD STEM SIZE5 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180763 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention