BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 LAT

    MDR report key: 6095832 · Received November 11, 2016

    Report

    Report Number
    3005180920-2016-00582
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    December 15, 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

    ON 18 NOVEMBER 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM LOOSENING IN CEMENTLESS THA AFTER 5 YEARS. THE STEM LOOKS RADIOGRAPHICALLY LOOSE PROXIMALLY AND RATHER SUBSIDED, ALTHOUGH A DISTAL PEDESTAL IS VISIBLE. THERE IS NO AP PELVIS RADIOGRAPH, SO THE LIMB LENGTH DISCREPANCY CANNOT BE VERIFIED, BUT IT IS LIKELY THAT THE OPERATED SIDE IS SHORTER, POSSIBLY DUE TO STEM SUBSIDENCE WHICH MUST HAVE HAPPENED BEFORE THE PEDESTAL WAS FORMED. SOME AREAS OF THE FEMUR LOOK LIKE OSTEOLYTIC REGIONS, BUT THERE IS NO COMMENT ON THIS ASPECT. THE MATERIAL OF THE INSERT IS NOT SPECIFIED. THE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ON 30 NOVEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED EXPLANTS AND COMMENTED AS FOLLOWS: THE PIECES WERE ANALYZED. THE STEM SHOWED A TOTAL ABSORPTION OF THE HA COATING IN THE DISTAL PART, WHILE IT REMAINED IN THE MEDIUM AND PROXIMAL AREAS. SOME SCRATCHES WERE VISIBLE IN THE ANTERIOR REGION OF THE NECK. THE FEMORAL CERAMIC HEAD REMAINED ASSEMBLED WITH THE TAPER OF THE STEM AND TWO SIGNS WERE VISIBLE IN THE SURFACE, PROBABLY RELATED TO THE PHASE OF REMOVAL. FROM THE ANALYZED PIECES IT IS NOT POSSIBLE TO DETERMINE A CERTAIN ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016 AND INCLUDES THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2016. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 111706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JULY 2011. EXPIRATION DATE: 2016-06-30. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN IN THE HIP. AFTER INVESTIGATING THE SURGEON FOUND THAT THE STEM WAS LOOSENED. A REVISION SURGERY WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748656 AMISTEM H, HA COATED STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 111706

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention