BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 9178288 · Received October 11, 2019

    Report

    Report Number
    3005180920-2019-00857
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    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 ON 23 SEPTEMBER 2019. LOT 140747: 86 ITEMS MANUFACTURED AND RELEASED ON 30-APR-2014. EXPIRATION DATE: 2019-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 86 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER. LATE INFECTION IN CEMENTLESS THA, MORE THAN 5 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 (K122911) LOT. 140831. BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2019. LOT 140831: 100 ITEMS MANUFACTURED AND RELEASED ON 17-APR-2014. EXPIRATION DATE: 2019-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 99 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    LOOSENING DUE TO INFECTION OF AN AMISTEM H 2 STD AND VERSAFITCUP CC TRIO 50MM. STEM AND CUP WERE SUCCESSFULLY REVISED. MORE THAN 5 YEARS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976936 STEM: AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 140747 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention