BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING FEMORAL

    MDR report key: 20961927 · Received December 18, 2024

    Report

    Report Number
    3005180920-2024-01021
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-11-2024: LOT 171686: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-07-2017. EXPIRATION DATE: 2022-08-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A REVISION SURGERY WAS PERFORMED ABOUT 6.5 YEARS AFTER THE PRIMARY IMPLANTATION OF A THA. THE COMPLAINED OF PAIN AND UNDERWENT FOLLOW-UP X-RAY WHICH REVEALED RADIOLUCENCY LINES AROUND THE STEM, PARTICULARLY IN THE PROXIMAL REGION, ALONG WITH SIGNS OF STRESS SHIELDING AND POSSIBLE SLIGHT SUBSIDENCE. THE BONE AROUND THE DISTAL APEX OF THE STEM EXHIBITED HIGH DENSITY AND CORTICAL THICKENING. 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 EXACTLY DETERMINED. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS AND 7 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING PAIN, DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719487 AMISTEM-H PROXIMAL COATING FEMORAL HIP STEM PROXIMAL COATING CEMENTLESS LPH MEDACTA INTERNATIONAL SA 01.18.186 171686

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention