BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 3 LAT

    MDR report key: 5050363 · Received September 2, 2015

    Report

    Report Number
    3005180920-2015-00184
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    July 31, 2015
    Report Date
    November 27, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2015: LOT 141478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JUNE 2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 2ND SEPTEMBER 2015 THE R&D PROJECT MANAGER CHECKED THE PICTURES OF THE EXPLANTED STEM WITH THE FOLLOWING COMMENTS: OBSERVING THE EXPLANTED FEMORAL STEM, ON ONE SIDE PRESENCE OF HA COATING CAN BE NOTICED MAINLY IN THE PROXIMAL PART OF THE PROSTHESIS AND AROUND THE TIP. WHILE, THE HA COATING IS NOT PRESENT IN THE CENTRAL PART OF THE STEM. FEW BONE CAN BE SEEN. ON THE OTHER SIDE, A SMALL STRIP OF HA COATING CAN BE SEEN ALONG THE STEM. A SMALL AMOUNT OF BONE CAN BE SEEN ATTACHED TO THE COATING. NO CONCLUSION CAN BE DETERMINED BY THE VISUAL INSPECTION. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. ON 2ND SEPTEMBER WE GOT THE CONFIRMATION THAT NO X-RAY IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION DUE TO AMISTEM-H LOOSENING 10 MONTHS AFTER PRIMARY, THE CUP WAS WELL FIXED BUT REMOVED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581304 AMISTEM H CEMENTLESS STEM SIZE 3 LAT HA COATED CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 141478

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention