BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE2

    MDR report key: 8319899 · Received February 8, 2019

    Report

    Report Number
    3005180920-2019-00037
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HEAD AND LINER REVISION OCCURRED 1 MONTH AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY. STEM SUBSIDENCE MAY BE DUE TO A SLIGHTLY UNDERSIZED STEM. THE REASON OF THIS CHOICE CANNOT BE ASSESSED HAVING A SINGLE ANTERO-POSTERIOR RADIOGRAPHIC PROJECTION. NO INFORMATION CONCERNING PATIENT BMI, AGE AND BONE QUALITY IS AVAILABLE. THE REASON OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. BATCH REVIEW PERFORMED ON 07 FEBRUARY 2019: LOT 180757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2018. EXPIRATION DATE: 2023-05-23. 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, 1 MONTH AND A HALF AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A SUBSIDED STEM. THE SURGEON CHOOSES TO LEAVE THE STEM IN PLACE BUT REVISED HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113749 STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180757 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention