BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE4

    MDR report key: 7185274 · Received January 12, 2018

    Report

    Report Number
    3005180920-2017-00828
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    December 13, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON (B)(6) 2017: 4.5 YEARS AFTER PRIMARY CEMENTLESS DOUBLE MOBILITY THA THE PATIENT SUFFERED A PERIPROSTHETIC FRACTURE, SUPPOSEDLY DUE TO A TRAUMATIC EVENT, WHICH CAUSED SUBSIDENCE OF THE FEMORAL THAT NEEDED REPLACEMENT. THIS ADVERSE EVENT DOES NOT SEEM TO BE IN ANY WAY RELATED TO A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 05 JANUARY 2018: LOT 130049: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE 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 INSTABILITY. THE SURGEON DETERMINED THAT HE STEM HAD SUBSIDED OVER TIME DUE TO A FRACTURE OF THE FEMUR DURING THE PRIMARY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28632 AMISTEM H HA COATED STD STEM SIZE4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 130049 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention