BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 8202405 · Received December 28, 2018

    Report

    Report Number
    3005180920-2018-01042
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    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 124043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 NOVEMBER 2012 . EXPIRATION DATE:31.10.2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON (B)(4) 2018 HIP REVISION SURGERY OCCURRED 5 YEARS AND 10 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. THE BONE QUALITY SEEMS TO HAVE WORSENED CONSIDERABLY, ALSO IN THE NON-OPERATED FEMUR. THE POSTOPERATIVE AND THE PRE-REVISION XRAY ARE TAKEN AT DIFFERENT ROTATIONS, BUT EVEN SO WE HAD THE IMPRESSION THAT THE FEMORAL ANGLE IN THE FRONTAL PLANE HAS CHANGED MORE THAN CUSTOMARY AND WE WERE WONDERING IF THE LADY GOT A KNEE OPERATION IN THE MEANTIME. WE ALSO ASSUME THAT IN SPITE OF THE LOOKS OF THE BONE THE POSSIBILITY OF AN INFECTION HAS BEEN RULED OUT. WITH ALL THIS, WE WERE UNABLE TO FIND A SOUND EXPLANATION FOR THE EVENT AND WE CANNOT BUT ASCRIBE IT TO ASEPTIC LOOSENING, A POSSIBLE COMPLICATION OF THA, WHOSE CAUSES VERY OFTEN CAN NOT BE FOUND.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO ASEPTIC LOOSENING OF THE STEM AFTER ABOUT 5 YEARS AND 10 MONTHS FROM PRIMARY (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041896 AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 124043 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention