BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 7

    MDR report key: 8906041 · Received August 19, 2019

    Report

    Report Number
    3005180920-2019-00688
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 26, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    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 DEPARTMENT: FEMORAL COMPONENT REVISION SURGERY PERFORMED 6 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, GENERAL HEALTH STATUS AND COMORBIDITIES IS AVAILABLE. RADIOGRAPHIC IMAGE PROVIDED SHOWS AN ABNORMAL BONE REACTION BUT NO ELEMENT IS AVAILABLE TO DEFINE THE CAUSES OF THIS. THE REASON OF THIS EVENT CANNOT BE DETERMINED ON THE BASIS OF INFORMATION COLLECTED. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 29-JULY-2019 BY REGULATORY AFFAIRS DEPARTMENT. LOT 110559: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2011. EXPIRATION DATE: 2016-03-31. (B)(4) ITEM HAS BEEN RESTERILIZED AND RELEASED ON 07-OCT-2015, EXPIRATION DATE 2020-09-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) ITEMS HAVE BEEN RESTERILIZED AND RELEASED ON 26-JULY-2016, EXPIRATION DATE 2021-07-06. (B)(4) ITEM HAS BEEN RESTERILIZED AND RELEASED ON 24-OCT-2016, EXPIRATION DATE 2021-10-03. (B)(4) ITEM HAS BEEN RESTERILIZED AND RELEASED ON 23-NOV-2016, EXPIRATION DATE 2021-11-08. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD 6 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. WE WERE INFORMED ABOUT THE EVENT ON AUGUST 20TH, THE REVISION SURGERY HAS BEEN PERFORMED ON AUGUST 26TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700608 STEM: AMISTEM H HA COATED STD STEM SIZE 7 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 110559 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention