BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS SOLID STEM LAT SIZE 10

    MDR report key: 17594766 · Received August 22, 2023

    Report

    Report Number
    3005180920-2023-00645
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888823
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02-AUG-2023. LOT 2100584: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. EXPIRATION DATE: 2026-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 5 DAYS POST PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY, DUE TO A PERIPROSTHETIC FRACTURE. IT IS UNKNOWN IF A TRAUMATIC EVENT OCCURRED. HOWEVER, WEAKENING OF THE BONE DURING SURGICAL FEMORAL PREPARATION IS A KNOWN POSSIBLE COMPLICATION OF THA. THIS MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE DURING REHABILITATION. FROM THE RADIOGRAPHIC IMAGES, IT IS VISIBLE THAT A QUADRA P WAS IMPLANTED AND THE BONE WAS CABLED TO FIX THE FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION DUE TO PERIPROSTHETIC BONE FEMORAL FRACTURE, AT ABOUT 5 DAYS POST PRIMARY. IT IS UNKNOWN IF A TRAUMATIC EVENT OCCURRED. A QUADRA STEM HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310409 SMS SOLID STEM LAT SIZE 10 HIP STEM LZO MEDACTA INTERNATIONAL SA 2100584 07630030888823

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention