BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P 01.18.464 AMISTEM- P SHORT NECK STD STEM SIZE 4

    MDR report key: 12352936 · Received August 23, 2021

    Report

    Report Number
    3005180920-2021-00662
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971243682
    PMA / PMN Number
    K192126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FRACTURE IN THE CALCAR REGION. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    OBLIQUE BONE FRACTURE AROUND THE TIP OF THE FEMORAL STEM WAS REPORTED. THE FRACTURE LED TO STEM SUBSIDENCE. THE SUBSIDENCE WAS OBSERVED ABOUT 2-3 WEEKS AFTER THE PRIMARY SURGERY. THE BONE WAS FIXED WITH A PLATE. NO IMPLANTS WERE REVISED. ADDITIONAL SURGERY DATE IS UNKNOWN.

    Description of Event or Problem · 0

    OBLIQUE BONE FRACTURE AROUND THE TIP OF THE FEMORAL STEM WAS REPORTED. THE PATIENT WAS HOSPITALIZED. NO REVISION IS PLANNED AT THE MOMENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JULY 2021: LOT 2002212: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUL-2020. EXPIRATION DATE: 2025-07-17. 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 · 1

    OBLIQUE BONE FRACTURE AROUND THE TIP OF THE FEMORAL STEM WAS REPORTED. THE PATIENT WAS HOSPITALIZED. NO REVISION IS PLANNED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250383 STEM: AMISTEM P 01.18.464 AMISTEM- P SHORT NECK STD STEM SIZE 4 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.464 2002212 07630971243682

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention