BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 8 STD

    MDR report key: 5828776 · Received July 28, 2016

    Report

    Report Number
    3005180920-2016-00387
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 28, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JULY 2016. LOT 100544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MAY 2010. EXPIRATION DATE: 2015-04-30. 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. ON 27 JULY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM REVISION IN CEMENTLESS THA 5 YEARS AFTER PRIMARY. AT PRE-REVISION X-RAY, THE STEM IS EVIDENTLY RADIOGRAPHICALLY LOOSE, SITUATION CONFIRMED AT SURGERY. DOUBLE-CONTOUR IS ALSO APPARENT ON CONTRALATERAL STEM. IMPLANT LOOSENING IS A KNOWN, POSSIBLE ADVERSE EVENT OF THA. THIS PARTICULAR PATIENT SHOWS FIXATION PROBLEMS IN BOTH FEMURS, BUT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO ESTABLISH A PLAUSIBLE CAUSE FOR THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED SOME MONTHS BEFORE THIS REPORT WITH HIP PAIN. THE SURGEON BELIEVED THE PATIENT'S PAIN WAS DUE TO LOOSENING OF THE STEM. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. THE STEM WAS OBSERVED TO BE LOOSE AND WAS REMOVED WITHOUT DIFFICULTY. THERE WAS NO EVIDENCE OF BONY ON-GROWTH. THE CUP AND LINER WERE LEFT IN-SITU AND THE STEM AND HEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482016 AMISTEM H, HA COATED STEM SIZE 8 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 100544

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention