BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.138 HA COATED STD STEM SIZE 8

    MDR report key: 15509010 · Received September 29, 2022

    Report

    Report Number
    3005180920-2022-00731
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804144
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 1 SEP 2022. LOT 143636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2014. EXPIRATION DATE: 2019-JUN-30. 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 DIRECTOR: REVISION AT 7 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY IN A MALE PATIENT DUE TO PAIN. ACCORDING TO REPORT, THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM, HEAD, AND LINER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. FROM THE RADIOGRAPHIC IMAGE PROVIDED, SIGNS OF STRESS SHIELDING ARE VISIBLE, THE SEM SEEMS TO HAVE FOUND STABILITY ONLY IN THE DISTAL PART. IT APPEARS THAT THE REVISED LIMB IS SHORTER BUT WE CANNOT TELL IF THIS CONDITION IS THE RESULT OF SECONDARY STEM SUBSIDENCE OR IF IT WAS PRESENT AFTER INDEX OPERATION. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. AT 7 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD, AND LINER WITH COMPETITOR COMPONENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886646 STEM: AMISTEM H 01.18.138 HA COATED STD STEM SIZE 8 HIP HA COATED STD STEM LZO MEDACTA INTERNATIONAL SA 01.18.138 143636 07630030804144

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention