BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 2

    MDR report key: 15217367 · Received August 12, 2022

    Report

    Report Number
    3005180920-2022-00606
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 18, 2022
    Report Date
    August 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720113
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-JUL-2022. LOT 2010559: 55 ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2021. EXPIRATION DATE: 2025-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION 1 YEAR AFTER INDEX SURGERY IN A 71 YEAR OLD MALE PATIENT DUE TO STEM LOOSENING. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. ONLY ONE RADIOGRAPH IS AVAILABLE AND WE ASSUME IT IS THE PRE-REVISION IMAGE. THERE SEEMS TO BE LITTLE OR NO CONTACT BETWEEN BONE AND STEM, AT LEAST IN THIS VIEW. THE STEM COULS HAVE BEEN UNDERSIZED AT INDEX SURGERY OR IT COULD HAVE REABSORBED FOR UNKNOWN REASONS. THE REPORT SAYS NO INFECTION IS PRESENT BUT WE ARE NOT SURE THAT THIS IS THE RESULT OF A THOROUGH ANALYSIS, GIVEN THE DATE OF THE EVENT WHICH COINCIDES WITH THE DATE OF THE REPORT. THE REASON OF THIS FAILURE CANNOT BE FULLY DETERMINED.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, AN HIP REVISION SURGERY ON THE RIGHT SIDE WAS PERFORMED DUE TO STEM LOOSENING. NO ACETABULAR LOOSENING AND NO INFECTION DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995837 STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 2 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.412 2010559 07630040720113

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention