BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM AMISTEM H CEMENTLESS SIZE 7

    MDR report key: 8377331 · Received February 28, 2019

    Report

    Report Number
    3005180920-2019-00101
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 131576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUL-2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP REVISION SURGERY OCCURRED 5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF OSTEOLYTIC REGIONS IN GRUEN ZONES 1 AND 7 AND SIGNS OF STRESS-SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP REPLACEMENTS AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY, PLANNED FOR (B)(6) 2019, SO 5 YEARS AND TWO MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173061 STEM AMISTEM H CEMENTLESS SIZE 7 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 131576 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention