BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM HA COATED LAT STEM SIZE 3

    MDR report key: 9097725 · Received September 20, 2019

    Report

    Report Number
    3005180920-2019-00775
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 AUGUST 2019: LOT 121495: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY (B)(6) MEDICAL MANAGER: HIP REVISION SURGERY PERFORMED 6 YEARS AND 7 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONE 1 AND 7, PEDESTAL AND SIGNS OD STRESS SHIELDING SUGGESTING IMPLANT MOBILIZATION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS THA AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON THE (B)(6) 2019 WE WERE INFORMED OF A REVISION SURGERY PLANNED AND PERFORMED DUE TO STEM LOOSENING ALMOST 6 YEARS AND 7 MONTHS AFTER PRIMARY. AMISTEM-H 3 LAT REPLACED WITH QUADRA-H 5 LAT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895218 AMISTEM HA COATED LAT STEM SIZE 3 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 121495 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention