BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 6 STD

    MDR report key: 5124162 · Received October 2, 2015

    Report

    Report Number
    3005180920-2015-00223
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    September 2, 2015
    Report Date
    November 4, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 IT WAS COMMUNICATED THAT THE RECOVERY OF THE PATIENT WAS FORESEEN FOR THAT DAY. ON (B)(4) 2015 IT WAS ADDED THAT NO REVISION WAS PREFORMED NOR PLANNED. ON (B)(4) 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 OCTOBER 2015: LOT 131637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED 3 YEARS AFTER PRIMARY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652192 AMISTEM H FEMORAL STEM SIZE 6 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 131637

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention