BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 5

    MDR report key: 8949800 · Received August 30, 2019

    Report

    Report Number
    3005180920-2019-00720
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804212
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 6 AUGUST 2019: LOT 178460: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-26. 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: NINE MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT IS COMPLAINING ABOUT PAIN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT AREAS AROUND THE STEM SUGGESTING IMPLANT LOOSENING AND DISTAL FIXATION. SUCH AN EARLY EVOLUTION TOWARDS ASEPTIC LOOSENING IS UNUSUAL AND WE DO NOT HAVE SUFFICIENT INFORMATION TO FIND AN EXPLANATION FOR IT. THERE ARE NO INDICATIONS THAT THE DEVICE HAS SHOWN ANY INTRINSIC DEFECTS, BUT THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED ON (B)(6) 2019 DUE TO PAIN (10 MONTHS AFTER PRIMARY SURGERY), THE STEM IS DISTALLY FIXED AND NOT IN THE PROXIMAL PART, POTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745891 AMISTEM H HA COATED LAT STEM SIZE 5 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 178460 07630030804212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention