BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM #3 LAT

    MDR report key: 4649489 · Received March 25, 2015

    Report

    Report Number
    3005180920-2015-00044
    Event Type
    Injury
    Date Received
    March 25, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03/25/2015: LOT 091151: (B)(4) STEMS PRODUCED AND RELEASED ON 06/04/2009. NO ANOMALIES FOUND. TO DATE, ALL THE STEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. ON 03/24/2015 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: THE PREOPERATIVE X-RAYS OF THE PRIMARY INTERVENTION ARE NOT AVAILABLE. IT MUST HAVE BEEN A DIFFICULT CASE BECAUSE APPARENTLY A FEMORAL OSTEOTOMY WAS PERFORMED. THE PROXIMAL PART OF THE FEMUR DID NOT OSTEOINTEGRATE AND THEREFORE THE STEM SUBSIDED. THERE ARE NO ELEMENTS TO THINK THAT IT COULD BE A DEVICE/RELATED PROBLEM.

    Additional Manufacturer Narrative · 1

    ON JULY 9, 2015, IT WAS PREPARED A FINAL REPORT WITH THE INFO COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON THE SAME DAY, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199120 AMISTEM H CEMENTLESS STEM #3 LAT CEMENTLESS FEMORAL STEM MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1