BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 LAT

    MDR report key: 5058325 · Received September 4, 2015

    Report

    Report Number
    3005180920-2015-00189
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    August 5, 2015
    Report Date
    November 6, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 NOVEMBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2015: LOT 130063: 51 ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON (B)(6) 2015 THE MEDICAL AFFAIRS DIRECTOR CHECKED THE X-RAY WITH THE FOLLOWING ANALYSIS: FEMORAL STEM LOOSENING IN A VERY HEAVY PATIENT. THE SURGEON REPORTS A CORTICOSTEROID TREATMENT SHORTLY AFTER PRIMARY IMPLANTATION. THE STEM WAS LOOSE ON MOST OF ITS SURFACE. POSSIBLY SLIGHTLY POSITIONED IN VARUS, BUT THIS COULD HARDLY BE DEFINED AS THE ROOT CAUSE FOR LOOSENING. THE ROOT CAUSE IS NOT ASCERTAINED WITH THE AVAILABLE INFORMATION. ON (B)(6) HE ADDED: POST-REVISION XRAYS WERE RECEIVED. THEY DO NOT ADD ANY USEFUL INFORMATION TO THE CLINICAL EVALUATION OF THE PRIMARY FAILURE. NOT RETURNED YET.

    Additional Manufacturer Narrative · 1

    ON 08 SEPTEMBER 2015 WE RECEIVED BACK THE IMPLANTS. ON 18 SEPTEMBER 2015 THEY WERE VISUALLY INSPECTED BY THE R&D PROJECT MANAGER: OBSERVING THE FEMORAL HEAD NO PARTICULAR SIGN CAN BE NOTED. OBSERVING THE FEMORAL STEM THE HA WAS NOT ABSORBED IN THE PROXIMAL PART. SOME HA CAN BE SEEN ALSO IN THE DISTAL PART OF THE STEM. NO BONE CAN BE SEEN ON THE STEM. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 10 MONTHS AFTER PRIMARY, DUE TO AMISTEM H LOOSENING. THE STEM WAS REMOVED EASILY AS IT WAS NOT TIGHTLY GRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586794 AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 130063

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR