BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 7450625 · Received April 23, 2018

    Report

    Report Number
    3005180920-2018-00259
    Event Type
    Death
    Date Received
    April 23, 2018
    Date of Event
    March 24, 2018
    Report Date
    April 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SENT IN ORDER TO CORRECT THE INITIAL 30 DAYS REPORT, IN WHICH, BY MISTAKE WE FLAGGED "DEATH", INSTEAD OF "SERIOUS INJURY" THAT SHOULD HAVE BEEN THE RIGHT ANSWER.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 APRIL 2018. LOT 173434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20.09.2017, EXPIRATION DATE: 2022-09-11. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 23 APRIL 2018: POSTOPERATIVE FEMORAL FRACTURE, FEW WEEKS AFTER PRIMARY CEMENTLESS THA IN A (B)(6) YEAR OLD WOMAN. THE FRACTURE MAY HAVE OCCURRED DURING WALKING RE-EDUCATION PERIOD OF TIME WHEN A SUDDEN MOVEMENT ON A FEMORAL BONE WEAKENED BY THE NORMAL INTRAOPERATIVE PREPARATION COULD HAVE FAVOURED THE THIS EVENT. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 19 DAYS AFTER PRIMARY. THE SURGEON DETERMINED THE PATIENT HAD FRACTURED HER FEMUR. THE CAUSE OF THE FRACTURE IS UNDETERMINED. THERE WAS NO MENTION OF TRAUMA BY THE PATIENT. THE SURGEON REVISED THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295425 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 173434 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention