BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS FEMORAL STEM SIZE 5 STD

    MDR report key: 5290056 · Received December 11, 2015

    Report

    Report Number
    3005180920-2015-00324
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    October 16, 2015
    Report Date
    March 10, 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 10 FEBRUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 23 FEBRUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 153128: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-07-21. 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. NOT EXPLANTED.

    Description of Event or Problem · 1

    PATIENT WAS HAVING A PRIMARY HIP SURGERY. DURING THE SURGERY THE SURGEON NOTICED THAT THE PATIENT HAD A FRACTURE OF THE GREATER TROCHANTER. THE SURGEON FELT THE FRACTURE WOULD HEAL ON IT'S OWN AND THE PATIENT WAS FINE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO EXPLANTS. THERE ARE NO X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821123 AMISTEM H CEMENTLESS FEMORAL STEM SIZE 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention