BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID GLENOID TRIAL PS 4MM LARGE

    MDR report key: 1691420 · Received May 17, 2010

    Report

    Report Number
    1825034-2010-00173
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED COMPONENT FOUND SOME SCRATCHES AND NOTCHES AROUND THE EDGE OF THE PROXIMAL RIM. THERE WERE ALSO SCRATCHES AND GOUGES ON THE ARTICULATING SURFACE AND SCRATCHES ON THE PERIMETER EDGES. THE FRACTURE SURFACE HAS RATCHET MARKS ALONG BOTH SIDE EDGES THAT SUGGEST A FATIGUE FRACTURE. (B) (4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A SHOULDER PROCEDURE ON (B) (6) 2010. THE SURGEON PLACED A TRIAL GLENOID INSIDE THE PATIENT TO GAUGE THE SIZE OF GLENOID IMPLANT REQUIRED. UPON REMOVAL, ONE OF THE PEGS FROM THE GLENOID TRIAL WAS STILL IN THE PREPARED HOLE. UNINTENTIONALLY, THE PEG WAS EVENTUALLY PUSHED FURTHER INTO THE PREPARED HOLE AND LOST BEHIND THE PATIENT¿S GLENOID. THE SURGEON WAS UNABLE TO REMOVE THE PEG, AND AS A RESULT, THE PATIENT RETAINED A FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRID GLENOID TRIAL PS 4MM LARGE PROSTHESIS, ALIGNMENT IQO BIOMET ORTHOPEDICS N/A 161900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S