BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM P 01.18.409 AMISTEM-P STD STEM SIZE 9

    MDR report key: 12874312 · Received November 25, 2021

    Report

    Report Number
    3005180920-2021-00941
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720083
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 OCTOBER 2021. LOT 180737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2018. EXPIRATION DATE: 2023-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD M WITH A 36MM COCR HEAD XXL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773698 AMISTEM P 01.18.409 AMISTEM-P STD STEM SIZE 9 FEMORAL COMPONENT LZO MEDACTA INTERNATIONAL SA 01.18.409 180737 07630040720083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other