BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 5 STD

    MDR report key: 5819155 · Received July 25, 2016

    Report

    Report Number
    3005180920-2016-00379
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 25, 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 20 JULY 2016. LOT 110555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2011. EXPIRATION DATE: 2016-02-29. 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. ON 22 JULY 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL INVESTIGATION AND COMMENTED AS FOLLOWS: STEM LOOSENING IN A THA ON A LADY OF (B)(6) AFTER 5 YEARS. THE STEM APPEARS TO BE RADIOGRAPHICALLY LOOSE IN THE LATERAL PROXIMAL REGION AND ALSO, TO A LESSER EXTENT, IN THE MEDIAL AREA, THEREFORE REMOVAL IS NECESSARY. NO REASON CAN BE DETERMINED FOR THIS LOOSENING. ASEPTIC LOOSENING IN CEMENTLESS STEMS FOLLOWING THA IS A KNOWN POSSIBLE COMPLICATION THAT IDIOPATHICALLY AFFECTS A SMALL PERCENTAGE OF THE OPERATED JOINTS; A CLEAR CAUSE CANNOT ALWAYS BE FOUND. NOT AVAILABLE.

    Description of Event or Problem · 1

    REVISION BECAUSE OF STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472663 AMISTEM H, HA COATED STEM SIZE 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 110555

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention