BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM 0 STD

    MDR report key: 5694972 · Received June 2, 2016

    Report

    Report Number
    3005180920-2016-00259
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 4, 2016
    Report Date
    August 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 28 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 12 AUGUST 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 13 MAY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM REVISION OF A PRIMARY CEMENTLESS THA FEW WEEKS AFTER IMPLANTATION, DUE TO A LESSER TROCHANTER FRACTURE. THIS MAY HAVE BEEN CAUSED OR FACILITATED DURING FEMORAL PREPARATION: IT IS A KNOWN POSSIBLE ADVERSE EVENT OF THA PROCEDURES. THE STEM LOOKS UNDERSIZED, BUT THIS SHOULD NOT HAVE BEEN THE MAIN CAUSE FOR REVISION. THE ROOT CAUSE IS THEREFORE FRACTURE, CAUSE UNKNOWN, NO REASON TO SUSPECT THAT IT WAS ORIGINATED BY A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 01 JUNE 2016. LOT 153415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 NOVEMBER 2015. EXPIRATION DATE: 2020-10-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME DUE TO THE STEM LOOSENING. THE SURGEON FOUND THAT THE PATIENT HAD A FRACTURE OF THE LESSER TROCHANTER WHICH HE BELIEVES MAY HAVE CAUSED THE STEM TO LOOSEN. THE SURGEON REVISED THE STEM WITH A CEMENTED STEM AND CABLES TO STABILIZE THE HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349542 AMISTEM H, HA COATED STEM 0 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 153415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention