BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 20257008 · Received September 19, 2024

    Report

    Report Number
    3005180920-2024-00767
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2024 LOT 131570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUNE-2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449644 STEM: AMISTEM H HA COATED STD STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 131570 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention