BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP FRACTURE STEM BROACH/PROVISIONAL

    MDR report key: 2120591 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00496
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 14, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED COMPONENT IS VERY WORN FROM BEING USED BEYOND THE RECOMMENDED LIFETIME OF THE DEVICE. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON REAMED AND BROACHED UP TO 14MM. HOWEVER, THE 14MM STEM SAT ABOUT 5MM PROUD. THE SURGEON REPEATED REAMING AND BROACHING SEVERAL MORE TIMES. THE 14MM STEM TOGGLED IN THE FEMORAL CANAL, BUT STILL SAT PROUD. THE PROCEDURE WAS COMPLETED IMPLANTING A CEMENTED 12MM STEM THAT WAS ON HAND WITH NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP FRACTURE STEM BROACH/PROVISIONAL DEVICE, PROSTHESIS ALIGNMENT IQO BIOMET ORTHOPEDICS N/A 309500

    Patients

    Seq Age Sex Outcome Treatment
    1