BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLORY / HEAD MODULAR CALCAR RASP / PROVISIONAL

    MDR report key: 1844359 · Received September 24, 2010

    Report

    Report Number
    1825034-2010-00397
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    July 4, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS LOT IDENTIFICATION HAS NOT BEEN PROVIDED. REVIEW OF DESIGN CONFIRMS THAT NORMAL USE OF THIS INSTRUMENT SHOULD NOT AFFECT THE TIGHTNESS OF THE CLIP COMPONENT; CLIP IS INTENDED TO PREVENT THE SCREW FROM FALLING OUT OF THE RASP. THERE IS NO TOOL TO BE USED TO REMOVE THE CLIP. IF DEVICE IS RETURNED AN EVALUATION WILL BE PERFORMED AND RESULTS WILL BE REPORTED. AS DEVICE HAS NOT BEEN RETURNED, NO FURTHER EVALUATION CAN BE PERFORMED. THIS REPORT SUBMITTED SEPTEMBER 24, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE ON (B)(6) 2010, THE SURGEON WAS RASPING THE PROXIMAL SIDE OF THE DEVICE WHEN THE LOCKING CLIP LOOSENED AND FELL OUT OF THE PROVISIONAL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY / HEAD MODULAR CALCAR RASP / PROVISIONAL DEVICE, PROSTHESIS ALIGNMENT IQO BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1