BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 9308985 · Received November 12, 2019

    Report

    Report Number
    3005180920-2019-00964
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    October 22, 2019
    Report Date
    November 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 OCTOBER 2019: LOT 1903333: 153 ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2019. EXPIRATION DATE: 2024-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 55 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    22 DAYS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT HIP FOR PERI-PROSTHETIC FEMUR FRACTURE. THE SURGEON REPLACED SUCCESSFULLY THE STEM USING A COMPETITOR DEVICE AND FIXED THE FRACTURE WITH WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104567 STEM: AMISTEM H HA COATED STD STEM SIZE 1 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1903333 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention