BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 7 LAT

    MDR report key: 5318754 · Received December 22, 2015

    Report

    Report Number
    3005180920-2015-00360
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    December 7, 2015
    Report Date
    March 29, 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

    ON 19 JANUARY 2016 THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS WITH THE FOLLOWING COMMENTS: 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 TOTALLY REABSORBED. VERY FEW BONES CAN BE NOTED ON THE SURFACE OF THE STEM. ON BOTH CERAMIC LINER AND FEMORAL HEAD SOME SCRATCHES CAN BE SEEN, PROBABLY CAUSED DURING THE REMOVAL PHASE. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THE CEMENTLESS STEM SANK PROGRESSIVELY OVER A PERIOD OF 4 YEARS, ACCORDING TO REPORT, UNTIL IT FOUND DISTAL STABILIZATION AND PROXIMAL RADIOLUCENCY WAS EVIDENT. THE HIP WAS THEREFORE PAINFUL. THE ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY; A HEAVY PATIENT VERY ACTIVE MAY HAVE BEEN TOO EXIGENT IN THE EARLY DAYS OF STABILIZATION. THERE ARE NOT SUFFICIENT INFORMATION TO DRAW A CONCLUSION OR TO FORMULATE A SOUND HYPOTHESIS. ON 29 FEBRUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS AND HERE ABOVE. ON 02 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT. 083628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2009. EXPIRATION DATE: 2013-12-31. 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 ANALYZED.

    Description of Event or Problem · 1

    THE SURGEON REVISED A LEFT THA HE DID IN 2011. THE PATIENT WAS (B)(6) AND AN ACTIVE TRADESMAN. THE SURGEON SUSPECTS NO PRIMARY FIXATION DUE TO EXCESSIVE ACTIVITY AS OVER THE COURSE OF 4 YEARS THE STEM HAS SUBSIDED APPROX 1 CM AND ENDED UP HAVING DISTAL FIXATION WITH PROXIMAL LUCENCY, DISTAL CORTICAL HYPERTHROPY AND THIGH PAIN. THE STEM WAS REMOVED EASILY VIA A POSTERIOR APPROACH AND A DIFFERENT STEM WAS USED. THE CERAMIC LINER HAD TO BE REMOVED TOO. A POLY LINER WAS USED TO REPLACE THE CERAMIC LINER THAT WAS REMOVED. THE SURGERY WAS COMPLETED WITHOUT INCIDENT AND THE MEDACTA COMPONENTS WERE SENT FOR STERILIZATION FOR RETURN TO MEDACTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844640 AMISTEM H CEMENTLESS STEM SIZE 7 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 083628

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention