BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 8202401 · Received December 28, 2018

    Report

    Report Number
    3005180920-2018-01043
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    November 30, 2018
    Report Date
    December 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    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 27 DECEMBER 2018: LOT 103218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. OTHER DEVICES: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E REFERENCE 01.26.3244HCT (K103352). LOT 103059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 NOVEMBER 2010 . EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MANUFACTURING PROCESS REVIEW HAS BEEN ASKED TO MANUFACTURER OF THE CERAMIX HEAD ON DECEMBER 11, 2018. REPORT RECEIVED ON DECEMBER 19, 2018 THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFILL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE. CLINICAL EVALUATION PERFORMED ON DECEMBER 13, 2018 BY MEDICAL AFFAIRS MANAGER: LATE INFECTION IN CEMENTLESS THA, 7 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 7 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING OCCURRED AFTER CHRONIC INFECTION WITH PROPION BACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041891 AMISTEM H HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 103218 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention