BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED SIZE 8 LAT

    MDR report key: 5991648 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00507
    Event Type
    Injury
    Date Received
    September 30, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2016. LOT 103235: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 DECEMBER 2010. EXPIRATION DATE: 2015-11-30. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 09 NOVEMBER 2016 AND INCLUDES: THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2016. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016 AND INCLUDES: IT WAS CONFIRMED THAT THE REVISION SURGERY HAS BEEN PERFORMED DUE TO STEM LOOSENING. ON 24 NOVEMBER 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED A FOLLOWS: STEM REVISION AT 5+ YEARS IN CEMENTLESS THA, IN A ROBUST MALE PATIENT WITH VALGUS HIP AND DORR TYPE A FEMURS. A CHALLENGING PREOPERATIVE CONDITION FOR CEMENTLESS THA; THE ARTICULAR GEOMETRIES LOOK WELL RESPECTED BUT THIS WAS ACHIEVED AT THE PRICE OF LEAVING THE STEM NOT VERY DEEPLY INSERTED IN THE FEMORAL CANAL, A CONDITION THAT MAY REDUCE THE STEM RESISTANCE TO TORSIONAL LOADS, PARTICULARLY IN A HEAVY PATIENT. THE LONGER STEM CHOSEN FOR REVISION MAY HAVE A BETTER CHANCE TO FUNCTION IN THESE CONDITIONS. FROM THE INFORMATION AVAILABLE, WE SHOULD NOT CONCLUDE THAT THE REVISION WAS CAUSED BY A DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED ON (B)(6) 2016 DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641624 AMISTEM H, HA COATED SIZE 8 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 103235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention