BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 1 STD

    MDR report key: 5318718 · Received December 22, 2015

    Report

    Report Number
    3005180920-2015-00346
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    November 27, 2015
    Report Date
    March 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 25 FEBRUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS. ON 02 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 WE RECEIVED THE INFORMATION THAT THE CULTURE WAS TAKEN IN ORDER TO KNOW IF THERE WAS AN INFECTION. THE FIRST RESULTS WERE NEGATIVE AND A SECOND SAMPLE WAS TAKEN. ON (B)(6) 2015 IT WAS FURTHER CONFIRMED THAT THE SECOND SAMPLE WAS NEGATIVE AGAIN. BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 132142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: 2018-06-30. 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. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 16 FEBRUARY 2016, THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS AND COMMENTED AS FOLLOWS: OBSERVING THE FEMORAL STEM NO PARTICULAR SIGN CAN BE NOTED, EXCEPT ON THE NECK: SUCH SIGNS WAS PROBABLY CAUSED DURING THE REMOVAL PHASE. THE HA ON THE SURFACE OF THE STEM IS REABSORBED, EXCEPT ABOUT THE FIRST 2MM UNDER THE CUT PLANE. REALLY FEW BONES CAN BE SEEN ON THE SURFACE OF THE STEM. THE CERAMIC FEMORAL HEAD SHOWS SOME SCRATCHES PROBABLY CAUSED BY THE REVISION SURGERY. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    REVISION DUE TO STEM LOOSENING 2 YEARS AFTER THE PRIMARY SURGERY. A SAMPLE WAS TAKEN IN ORDER TO KNOW IF THE PATIENT HAD AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843709 AMISTEM H CEMENTLESS STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 132142

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention