BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STD STEM SIZE 4

    MDR report key: 17029861 · Received May 31, 2023

    Report

    Report Number
    3005180920-2023-00403
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    November 14, 2022
    Report Date
    May 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BACH REVIEW PERFORMED ON 12-MAY-2023LOT 182770: (B)(4) MANUFACTURED AND RELEASED ON 03-AUG-2018. EXPIRATION DATE: 2023-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEADACTA MEDICAL AFFAIRS MANAGER: ACCORDING TO REPORT, DURING A FOLLOW UP VISIT MORE THAN 2 YEARS AFTER THE INDEX THA SURGERY, IT WAS REVELEAD FROM THE RADIOGRAHIC IMAGES THAT THE STEM SUBSIDED AND RADIOLUCENT LINES WERE VISIBLE. SURGEON IS EVALUATING A POSSIBLE REVISION SURGERY. THE RADIOGRAPHIC HISTORY SHOWS A PROGRESSIVE DEVELOPMENT OF PROXIMAL RADIOLUCENT LINES AND A POTTED STEM AT 1 YEAR. SUBSEQUENTLY, SUBSIDENCE OCCURRED AND IT IS NOT KNOWN IF A RELIABLE STABILITY HAS BEEN ACHIEVED. THE REASON OF THIS FAILURE CANNOT BE DETERMINED BUT THERE IS NO REASONS TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    POST-OP X-RAYS REVEALED RADIOLUCENT LINES AND STEM SINKING, MORE THAN 2 YEARS AFTER THE PRIMARY. THE BONE ABOVE THE LESSER TROCHANTER IS MISSING. THE SURGEON IS EVALUATING A POSSIBLE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682634 AMISTEM H, HA COATED STD STEM SIZE 4 HIP CEMENTLES STEM LZO MEDACTA INTERNATIONAL SA 01.18.134 182770 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other