BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 4

    MDR report key: 17798754 · Received September 22, 2023

    Report

    Report Number
    3005180920-2023-00709
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804205
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 AUGUST 2023. LOT 141479: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUNE-2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 6 YEARS 6 MONTHS AFTER THE PRIMARY THA, DUE TO A LOOSE STEM. RADIOGRAPHIC IMAGE PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONE 7 AND SIGNS OF STRESS SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION BY R&D PROJECT MANAGER: LOOKING AT THE IMAGE ATTACHED TO THE COMPLAINT IT IS VISIBLE THE STEM BODY COVERED BY PATIENT BLOOD. IT SEEM THAT THE HA COATING IS NOT PRESENT ON THE STEM BODY, BUT THIS IS NOT COMPLETELY CLEAR FROM THE IMAGE. ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE 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 NECK OF 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 6 YEARS 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH A NEW STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486163 STEM: AMISTEM H HA COATED LAT STEM SIZE 4 HIP STEM LZO MEDACTA INTERNATIONAL SA 141479 07630030804205

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention