BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM BROACH SIZE 0

    MDR report key: 5510669 · Received March 18, 2016

    Report

    Report Number
    3005180920-2016-00102
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    February 18, 2016
    Report Date
    June 16, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 1213486: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. AMISTEM H, HA COATED STEM SIZE 4 STD, CODE 01.18.134, LOT. 153975 (K093944); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND ANOTHER SIMILAR EVENT HAS BEEN ALREADY REPORTED ON AN ITEM OF THE SAME LOT (MDR 2016-00056). NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 18 MAY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 23 MAY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    WHEN BROACHING THE PATIENT WITH A SIZE 0 BROACH, THE GREATER TROCHANTER WAS FRACTURED. THE SURGEON CONTINUED TO BROACH TO A SIZE 4. WHEN THE SURGEON IMPLANTED THE SIZE 4 STEM A SECOND FRACTURE OCCURRED ON THE FEMUR. THE SURGEON PLATED THE FEMUR WITH SCREWS AND CABLED THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO EXPLANTS OR X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166017 AMISTEM BROACH SIZE 0 SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1213486

    Patients

    Seq Age Sex Outcome Treatment
    1 Other