BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE1

    MDR report key: 12852043 · Received November 22, 2021

    Report

    Report Number
    3005180920-2021-00911
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804564
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE FEMORAL CALCAR FRACTURE DETECTED FEW DAYS AFTER PRIMARY SURGERY IN A (B)(6) YEAR OLD WOMAN. INTRAOPERATIVE FEMORAL FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS, DESCRIBED AND QUANTIFIED IN LITERATURE. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. ALSO, DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED HOWEVER, THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 04 NOVEMBER 2021. LOT 1900042: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-MAR-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    ABOUT 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON NOTICED ON THE X-RAY THAT A GREATER TROCHANTERIC FRACTURE IS VISIBLE, AND PERFORMED OSTEOSYNTHESIS USING A PLATE AND WIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE FRACTURE IS UNKNOWN, BUT IT MAY HAVE OCCURRED DURING EXTERNAL ROTATION OF THE FEMUR OR WHEN USING A STARTER REAMER OR RASP. THE BONE QUALITY WAS NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751970 AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE1 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.231 1900042 07630030804564

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention