BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3

    MDR report key: 16322499 · Received February 8, 2023

    Report

    Report Number
    3005180920-2023-00024
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 8, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720229
    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 12 JANUARY 2023 LOT 2116239: 60 ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2022. EXPIRATION DATE: 2027-FEB-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 56 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A GREATER TROCHANTER FRACTURE AND THE CAUSE IS UNKNOWN. ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REP SAID THAT THE SURGEON MENTIONED THAT IT IS A POSSIBILITY THAT THE FRACTURE COULD HAVE OCCURRED INTRA-OP DURING THE PRIMARY SURGERY BUT IT IS UNCERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313998 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.433 2116239 07630040720229

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention