BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1 LOT. 153416

    MDR report key: 15770538 · Received November 10, 2022

    Report

    Report Number
    3005180920-2022-00825
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 12, 2022
    Report Date
    November 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    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) 2022 LOT 153416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-SEP-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION OF THE STEM 6 YEARS AND 7 MONTHS AFTER THE INDEX THA DUE TO STEM LOOSENING IN A 63 YEAR OLD PATIENT. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES ARE VISIBLE. 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

    REVISION SURGERY PERFORMED ABOUT 6 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO IMPLANT ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639220 STEM: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1 LOT. 153416 HIP COATED STD STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 153416 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention