BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 8054913 · Received November 9, 2018

    Report

    Report Number
    3005180920-2018-00879
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 NOVEMBER 2018; LOT 152208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-07-13; 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON NOVEMBER 09, 2018 PARTIAL REVISION OF CEMENTLESS PRIMARY THA 3 YEARS AFTER INDEX OPERATION. THE INFORMATION AVAILABLE DOES NOT ALLOW A FULL ANALYSIS. WE HAVE SEEN POOR-QUALITY RADIOGRAPHS, DATE UNKNOWN, THAT SHOW A STEM IN A VARUS POSITION AND SITTING FAR TOO HIGH IN THE FEMUR. THE ACETABULAR CUP SEEMS TO HAVE VIOLATED THE LAMINA QUADRILATERAL, BUT APPARENTLY IT WAS NOT REMOVED. THESE CONDITIONS DO NOT DENOUNCE A DEFECTIVE PRODUCT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 3 YEARS AFTER PRIMARY SURGERY. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894893 AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 152208 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention