BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD UNV 5IN1 TIBIAL TRIAL 71/75X10

    MDR report key: 2543522 · Received April 20, 2012

    Report

    Report Number
    0001825034-2012-00496
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RETURNED DEVICE SHOWS THAT BEARING TRIAL EXHIBITS BOTH INDENTATIONS AND A FRACTURE, BUT IT IS UNKNOWN IF THE INDENTATIONS AND FRACTURE OCCURRED AT THE SAME TIME. IT IS CONCEIVABLE THAT USER TECHNIQUES AND TOOL IMPACT FORCES THAT CREATED THE INDENTATIONS COULD HAVE EVENTUALLY CONTRIBUTED TO THE FRACTURE. THERE ARE STRONG VISUAL SIGNS THAT THE TRIAL BEARING WAS FORCED INTO SPACES BETWEEN THE FEMORAL AND TIBIAL TRAY THAT WERE TOO NARROW TO ACCOMMODATE IT.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE, AS THE SURGEON WAS TRYING TO INSERT THE TIBIAL BEARING TRIAL, THE BEARING FRACTURED. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT'S WOUND AND THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD UNV 5IN1 TIBIAL TRIAL 71/75X10 TEMPLATE IQO BIOMET ORTHOPEDICS N/A 924740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R