BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 1 STD

    MDR report key: 5261164 · Received December 2, 2015

    Report

    Report Number
    3005180920-2015-00300
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    November 2, 2015
    Report Date
    February 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 DECEMBER 2015: LOT 150841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MAY 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    ON 28 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 FEBRUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING THE REHABILITATION, THE PATIENT'S FEMORAL BONE WAS FRACTURED. ACCORDING TO THE SURGEON, FEMORAL BONE WAS FRACTURED 5CM LONG. DUE TO THE HOSPITAL POLICY, X-RAY PICTURES AND RETRIEVED STEM ARE NOT AVAILABLE. FRACTURED BONE WAS REPAIRED USING WIRE AND REPLACED FEMORAL STEM WITH A CEMENTED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790758 AMISTEM H CEMENTLESS STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 150841

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention