BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12

    MDR report key: 8239790 · Received January 11, 2019

    Report

    Report Number
    3005180920-2018-01085
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 14, 2018
    Report Date
    January 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885723
    PMA / PMN Number
    K151531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JANUARY 2019. LOT 162136: 17 ITEMS MANUFACTURED AND RELEASED ON 31 MAY 2016. EXPIRATION DATE: 2021-05-22 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY PACKAGING AND WASHING MANAGER ON JANUARY 11, 2019, THE ROOT CAUSE RELATES TO THE COMBINED FACTORS OF ANOMALOUS SHIPPING/HANDLING CONDITIONS AND THE LIMITATION OF THE PACKAGING CONFIGURATION TO BE OPTIMALLY ROBUST TO ALL POSSIBLE SHIPPING STRESSES EXPERIENCED.

    Description of Event or Problem · 1

    DURING THE PRIMARY HIP SURGERY, IT WAS DISCOVERED THAT THE STEM HAD PENETRATED THE EXTERNAL PACKAGING. THERE WAS NO BACKUP STEM AVAILABLE, SO THE SURGEON CHOSE TO WASH AND IMPLANT THE STEM INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35327 MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 162136 07630030885723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other