BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 4 STD

    MDR report key: 5772393 · Received July 6, 2016

    Report

    Report Number
    3005180920-2016-00327
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 24 JUNE 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ASEPTIC LOOSENING OF CEMENTLESS THA, THE TIME IN SITU IS NOT KNOWN, BUT FROM THE ONE RADIOGRAPH AVAILABLE IT MAY BE SURMISED THAT SOME YEARS HAVE PASSED. CORTICAL HYPERTROPHY (MODERATE) IN GRUEN ZONE 4, AND CORTICAL THINNING IN GRUEN ZONES 6 AND 7. THE STEM MAY HAVE SLIGHTLY SUBSIDIZED OR THE INVOLVED LIMB WAS A LITTLE SHORTER. ASEPTIC LOOSENING IS A POSSIBLE KNOWN COMPLICATION FOR CEMENTLESS THA, NO PARTICULAR SIGN OF A DEFECTIVE IMPLANT IS DISCERNIBLE WITH THE INFORMATION AVAILABLE. ON 27 JUNE 2016 THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS: OBSERVING THE FEMORAL STEM NO PARTICULAR SIGN CAN BE NOTED, EXCEPT ON THE NECK: SUCH SIGNS WERE PROBABLY CAUSED DURING THE REMOVAL PHASE. THE HA ON THE SURFACE OF THE STEM IS STILL PRESENT IN THE PROXIMAL AREA. ON THE FEMORAL HEAD NO PARTICULAR SIGNS CAN BE SEEN, EXCEPT SOME SCRATCHES PROBABLY DUE TO THE REMOVAL PHASE. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 05 JULY 2016. LOT 103440: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOVEMBER 2010. EXPIRATION DATE: 2015-10-30. 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.

    Description of Event or Problem · 1

    THE SURGEON HAD TO REVISE THE STEM DUE TO LOOSENING. X-RAYS AND EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425454 AMISTEM H, HA COATED STEM SIZE 4 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 103440

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention