BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED STD STEM SIZE 4

    MDR report key: 19603234 · Received June 25, 2024

    Report

    Report Number
    3005180920-2024-00474
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 24, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720236
    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 10 JUNE 2024 LOT 2204067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2022. EXPIRATION DATE: 2027-05-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    PERIPROSTHETIC FEMORAL FRACTURE WAS CABLED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY. FRACTURE OCCURRED DURING PHYSIOTHERAPY. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208505 STEM: AMISTEM-P COLLARED STD STEM SIZE 4 HIP COLLARED STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 2204067 07630040720236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention