BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED LAT SIZE2

    MDR report key: 10991942 · Received December 11, 2020

    Report

    Report Number
    3005180920-2020-00886
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    November 13, 2020
    Report Date
    January 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 DECEMBER 2020: LOT 2000037: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2020. EXPIRATION DATE: 2025-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE PATIENT HAS NOT UNDERGONE A REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ONE MONTH AFTER PRIMARY CEMENTLESS THA A PERIPROSTHETIC FRACTURE OCCURS. THE INTRAOPERATIVE FLUOROSCOPY SHOWS A STEM CORRECTLY POSITIONED. THE REPORT DOES NOT MENTION ANY SIGNIFICANT TRAUMA, BUT OF COURSE IT DOESN'T MEAN THERE WASN'T ANY. TO DATE, WE CANNOT DRAW ANY CONCLUSION AS TO THE CAUSES OF THIS ADVERSE EVENT, AND WE CANNOT FIND HINTS OF A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE PATIENT HAS NOT UNDERGONE A REVISION SURGERY YET. MORE INFORMATION COULD BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458904 STEM: AMISTEM-P COLLARED LAT SIZE2 STEM CEMENTLESS COLLARED LZO MEDACTA INTERNATIONAL SA 2000037

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other