BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID SMS COLLARED SOLID STEM LAT SIZE 8

    MDR report key: 13731920 · Received March 11, 2022

    Report

    Report Number
    3005180920-2022-00164
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345701909
    PMA / PMN Number
    K203041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 FEBRUARY 2022. LOT 2102623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2021. EXPIRATION DATE: 2026-06-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS SPECIALIST. FEW DAYS AFTER PRIMARY CEMENTLESS THA A PERIPROSTHETIC FRACTURE OCCURS WITH NO TRAUMA REPORTED. IT IS CONCEIVABLE THAT DURING SURGERY, IN PARTICULAR DURING FEMORAL PREPARATION, THE BONE MAY HAVE BEEN WEAKENED AND A LEAST-RESISTANCE AREA MAY HAVE BEEN CREATED. THIS IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING THA AND THERE IS NO REASON TO SUSPECT THAT IT IS DUE TO A DEFECT IN THE IMPLANTED DEVICE OR IN THE PREPARING INSTRUMENTS.

    Description of Event or Problem · 0

    AT 14 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574122 STEM: SMS SOLID SMS COLLARED SOLID STEM LAT SIZE 8 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.36.168 2102623 07630345701909

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention