BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARD

    MDR report key: 2514231 · Received April 3, 2012

    Report

    Report Number
    0001825034-2012-00360
    Event Type
    Injury
    Date Received
    April 3, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICAL CONDITION OF THE TRIAL SUGGESTS INTERACTION WITH A SHARP SURGICAL INSTRUMENT AND THE FRACTURE OF THE DEVICE WAS CAUSED BY BENDING OVERLOAD. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6), 2012. DURING THE FINAL TRIAL REDUCTION PHASE, THE POST FRACTURED OFF THE TRIAL BEARING, AND HAD TO BE THE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY TO THE PROCEDURE, AND NO FOREIGN BODIES WERE RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARD DEVICE, PROSTHESIS ALIGNMENT IQO BIOMET ORTHOPEDICS N/A 477810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R