BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H HA COATED STD STEM SIZE 3

    MDR report key: 7153830 · Received December 29, 2017

    Report

    Report Number
    3005180920-2017-00794
    Event Type
    Injury
    Date Received
    December 29, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 29, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 22 DECEMBER 2017: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 3 DAYS AFTER PRIMARY IMPLANTATION DUE TO A CALCAR FRACTURE. THIS EVENT MAY BE DUE TO THE NORMAL INTRAOPERATIVE BONE WEAKENING CAUSED BY THE FEMORAL PREPARATION AND MAY HAVE OCCURRED AFTER WEIGHT BEARING DURING THE IMMEDIATE POSTOPERATIVE REHABILITATION PERIOD. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 29 DECEMBER 2017 LOT 170813: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 JUNE 2017. EXPIRATION DATE: 2022-05-25. 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

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT HAD A CALCAR FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934724 AMISTEM-H HA COATED STD STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.133 170813 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention