BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED 01.18.436 AMISTEM-P COLLARED STD STEM SIZE 6

    MDR report key: 18482446 · Received January 10, 2024

    Report

    Report Number
    3005180920-2023-01061
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 11, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720250
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-DEC-2023. LOT 1901536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2019. EXPIRATION DATE: 2024-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142007 STEM: AMISTEM-P COLLARED 01.18.436 AMISTEM-P COLLARED STD STEM SIZE 6 HIP COLLARED STD STEM LZO MEDACTA INTERNATIONAL SA 1901536 07630040720250

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention