BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0

    MDR report key: 17756462 · Received September 15, 2023

    Report

    Report Number
    3005180920-2023-00721
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 141457: 50 ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER: LOOKING AT THE STEM, IT IS VISIBLE THE ABSORPTION OF HA FROM THE STEM BODY, IT INDICATES THAT METABOLIC ACTIVITY WAS TAKING PLACE AND THAT, PRESUMABLY, ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. THE POST-OP X-RAY ANALYSIS COULD POSSIBLY PROVIDE MORE INSIGHT, SUCH AS THE EVALUATION OF POSSIBLE EARLY ROTATIONAL INSTABILITY OR INITIAL STRESS-SHIELDING. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM LOOSENING REPORTED.

    Description of Event or Problem · 0

    AT ABOUT 8 YEARS AND 4 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED SUCCESSFULLY ALL THE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303180 STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 141457 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention