BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8

    MDR report key: 10366566 · Received August 5, 2020

    Report

    Report Number
    3005180920-2020-00493
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720274
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JULY 2020: LOT 1810265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2019. EXPIRATION DATE: 2024-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE; THE CAUSE OF THE PERIPROSTHETIC FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833098 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8 HIP STEM LZO MEDACTA INTERNATIONAL SA 1810265 07630040720274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention