BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9

    MDR report key: 7662368 · Received July 4, 2018

    Report

    Report Number
    3005180920-2018-00476
    Event Type
    Injury
    Date Received
    July 4, 2018
    Date of Event
    June 4, 2018
    Report Date
    July 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885693
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED ON (B)(6) 2018 BY MEDICAL AFFAIRS DIRECTOR THE HISTORY OF THIS CASE IS NOT WELL DOCUMENTED. APPARENTLY, 4 MONTHS AFTER CEMENTLESS THA IN A WOMAN WITH VERY POOR BONE QUALITY A FEMORAL FRACTURE TOOK PLACE, WITH NO REPORTED TRAUMATIC EVENT. THE RADIOGRAPH SUPPLIED SHOWS A FRACTURED FEMUR BUT ALSO A CABLE-PLATING SYSTEM WHOSE APPEARANCE WE CANNOT DATE. THIS TYPE OF DEVICES IS NORMALLY USED TO TREAT FRACTURES OVER A FEMORAL STEM (WHEN NO SCREWS CAN BE INSERTED), BUT IF THAT IS WHAT HAPPENED, THE FRACTURE MUST HAVE REPEATED AFTER THE PLATING AND CABLING WAS DONE. IN ANY CASE, WE DO NOT SEE ANY PROBLEM THAT MAY HAVE BEEN CAUSED BY A FAULTY THA IMPLANT. BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 170628: 15 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD POOR BONE QUALITY AND FRACTURED HER FEMUR 4 MONTHS AFTER PRIMARY. THERE WAS NO REPORT OF TRAUMA. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504840 MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 170628 07630030885693

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention