BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL TRL HND/ALIGNMENT TOWER

    MDR report key: 3930085 · Received July 11, 2014

    Report

    Report Number
    0001825034-2014-06108
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 15, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND THE PART WAS CONFORMING TO PRINT SPECIFICATIONS WHEN IT LEFT BIOMET AND THAT THE SHORT PIN THAT CONTROLS THE RANGE OF MOTION OF THE MODULAR HEAD HAD FRACTURED DUE TO AN UNIDIRECTIONAL BENDING FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE HANDLE ALIGNMENT TOWER COULD NOT BE UTILIZED DUE TO A FRACTURE OF THE GRUB SCREW. ALL FRACTURED PIECES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406080 VANGUARD TIBIAL TRL HND/ALIGNMENT TOWER INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM BIOMET ORTHOPEDICS N/A ZB120602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention