BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID SMS SOLID STEM LAT SIZE 9

    MDR report key: 12834860 · Received November 18, 2021

    Report

    Report Number
    3005180920-2021-00889
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888816
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 OCTOBER 2021: LOT 2101519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. 2 MONTHS AFTER PRIMARY CEMENTLESS THA THE STEM SUBSIDES AND REQUIRES REVISION. ACCORDING TO THE IMAGES SUPPLIED, A POSSIBLE CAUSE WAS THE UNDERSIZING OF THE STEM. WE DO NOT HAVE ENOUGH INFORMATION TO UNDERSTAND THE REASONS THAT MAY HAVE LED THE SURGEON TO UNDERSIZE, IF HE DID. THE RESECTION LEVEL CHOSEN FOR THIS SURGERY WAS VERY HIGH (MOST OF THE FEMORAL NECK WAS PRESERVED), AND THIS MAY LEAD TO GIVE A FALSE SENSATION OF STABILITY EVEN THOUGH THE STEM SIZE IS NOT YET SUFFICIENT TO GUARANTEE RELIABLE PRIMARY STABILITY. THERE IS NO MENTION OF TRAUMATIC EVENTS THAT MAY HAVE LED TO FEMORAL FRACTURES, WHICH ARE NOT VISIBLE IN THE LOW-QUALITY PICTURES SUPPLIED. THE QUALITY OF THE IMAGES DOES NOT ALLOW A FULL EVALUATION OF THE BONE QUALITY, BUT IT APPEARS TO BE RATHER POOR, AND THIS MAY HAVE PREVENTED A SUFFICIENT STABILITY BY PRESS-FIT TO BE ACHIEVED AT SURGERY. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS SOME SCRATCHES WERE VISIBLE ON THE STEM NECK PROBABLY DUE TO REVISION SURGERY, IN ANY CASE THEY CANNOT RESULT IN STEM SUBSIDENCE EVEN IF PRESENT BEFORE THE REVISION. NO PRODUCTION DEFECTS WERE FOUND, THE MANUFACTURING CONTROL MEASURES WERE IN COMPLIANCE WITH THE DRAWINGS. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE SUBJECT STEM FAILURE THROUGH THE VISUAL INSPECTION.

    Description of Event or Problem · 0

    AT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A REVISION DUE TO STEM SUBSIDENCE AND MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735679 STEM: SMS SOLID SMS SOLID STEM LAT SIZE 9 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.36.069 2101519 07630030888816

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention