BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P SHORT NECK STD SIZE 5

    MDR report key: 11160605 · Received January 13, 2021

    Report

    Report Number
    3005180920-2021-00032
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 18, 2020
    Report Date
    January 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971243699
    PMA / PMN Number
    K192126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 2000108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2020. EXPIRATION DATE: 01-APR-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. ALSO THE PRESENCE OF AN INTRAOPERATIVE FISSURE, NOT VISIBLE IN THE IMMEDIATE POSTOP X-RAY, MAY BE A POSSIBLE CAUSE OF THIS EVENT. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE

    Description of Event or Problem · 1

    PRIMARY AMIS SURGERY WAS PERFORMED ON (B)(6) 2020. THE PATIENT HAD PAIN DUE TO BONE FRACTURE. REVISION SURGERY HAS BEEN SCHEDULED WITH COMPETITOR IMPLANTS ON (B)(6). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58877 STEM: AMISTEM P SHORT NECK STD SIZE 5 FEMOREAL STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.465 2000108 07630971243699

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention