BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 7276638 · Received February 16, 2018

    Report

    Report Number
    3005180920-2018-00056
    Event Type
    Injury
    Date Received
    February 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 FEBRUARY 2018: LOT 173489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 2017. EXPIRATION DATE: 2022-09-13. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO FEMUR BONE FRACTURE AFTER 13 DAYS FROM THE PRIMARY. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120716 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 173489 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention