BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 STD

    MDR report key: 5991571 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00501
    Event Type
    Injury
    Date Received
    September 30, 2016
    Report Date
    December 23, 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 (B)(6) 2016. LOT 140005: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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 23 NOVEMBER 2016 AND INCLUDES: REASON FOR REVISION WAS CONFIRMED AS LOOSENING AND PAIN. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED ON (B)(6) 2016, STEM, HEAD AND INLAY WERE EXPLANTED. THE PATIENT WAS FEMALE, ACTIVE, MIDDLE WEIGHT. ON 05 DECEMBER 2016 THE MEDICAL AFFAIRS (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PROGRESSIVE FEMORAL LOOSENING IN CEMENTLESS THA AT 2,5 YEARS. NO INDICATION AS TO THE REASON FOR THE LOOSENING CAN BE GATHERED FROM THE AVAILABLE INFORMATION, WHICH IS LIMITED TO THE PLAIN X-RAYS. THE STEM LOOKS CORRECTLY IMPLANTED, BUT THE BONE LOOKS IMPOVERISHED BOTH ON THE FEMORAL AND ACETABULAR SIDE, ALTHOUGH STILL AT AN INITIAL LEVEL. NO CONCLUSION CAN BE DRAWN, UNFORTUNATELY.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643786 AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 140005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention