BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 4

    MDR report key: 10654672 · Received October 9, 2020

    Report

    Report Number
    3005180920-2020-00687
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 9, 2020
    Report Date
    October 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804205
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 SEPTEMBER 2020 LOT 140773: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2014. EXPIRATION DATE: 2019-03-31. 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: HIP REVISION SURGERY PERFORMED 4 YEARS AND 9 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY IN AN ACTIVE PATIENT. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF A RADIOLOGICALLY LOOSENED STEM AND SIGNS OF STRESS SHIELDING. NO RADIOGRAPHIC HISTORY IS AVAILABLE TO JUDGE THE INITIAL POSITION AND DIMENSION OF THE STEM. NO COMMENTS WERE GIVEN AS TO THE POSSIBILITY OF AN INFECTION BEING ACTIVE. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED. PRELIMINARY ANALYSIS PERFORMED BY R&D PROJECT MANAGER: IS VISIBLE THAT THE IMPLANT IS COVERED WITH BIOLOGICAL FLUIDS, BASED ON THE PICTURES RECEIVED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE AT THIS PHASE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO STEM LOOSENING AFTER 4 YEARS AND 8 MONTHS FROM THE PRIMARY. THE PATIENT IS VERY ACTIVE, WHAT COULD BE A REASON FOR THE STEM LOOSENING. THE STEM AND THE HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118958 STEM: AMISTEM H HA COATED LAT STEM SIZE 4 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.144 140773 07630030804205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention