BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID SMS SOLID STEM STD SIZE 5

    MDR report key: 15265024 · Received August 22, 2022

    Report

    Report Number
    3005180920-2022-00630
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    July 23, 2022
    Report Date
    August 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888649
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 JULY 2022. LOT 2100572: (B)(4). EXPIRATION DATE: 2026-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 0

    [FU1 SENT ON THE SAME DAY OF THE INITIAL TO DUE HUMAN ERROR (CLINICAL EVALUATION NOT REPORTED IN THE INITIAL REPORT)] CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. REVISION 16 DAYS AFTER CEMENTLESS PRIMARY THA IN A MALE PATIENT DUE TO STEM SUBSIDENCE.THE SURGEON REVISED THE STEM, HEAD, AND LINER. TWO RADIOGRAPHIC IMAGES ARE PROVIDED, ONE AFTER THE INDEX SURGERY AND ONE AFTER THE REVISION. SINCE AN IMAGE RIGHT AFTER THE INDEX SURGERY IS NOT PROVIDED, IT IS NOT POSSIBLE TO EVALUATE THE ORIGINAL POSITION AND THE SIZING OF THE STEM . THE PRE-REVISION IMAGE SHOWS THE STEM SUBSIDED AND DISLOCATED FROM THE CUP, WHICH WAS PROBABLY DUE TO STEM SUBSIDENCE AND CONSEQUENT LOSS OF TENSION.

    Description of Event or Problem · 0

    AT 16 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422322 STEM: SMS SOLID SMS SOLID STEM STD SIZE 5 KNEE STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.36.045 2100572 07630030888649

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention