BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC + MAXROM TRIAL LINER SIZE 24 X 32 MM I.D.

    MDR report key: 2120487 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00484
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT HAD NO ANOMALY OR DEVIATION. THE TRIAL HAS SCRATCHES, GOUGES, AND WEAR MARKS ON MOST SURFACES. THE SCREW HEAD HAS SCRATCHES ON IT. THERE ARE DOME CRACKS AROUND THE FLANGE AND SOME OF THE POLYMER APPEARS MISSING AROUND THE EDGE OF THE HOLE. THE CRACKS AROUND THE DOME FLANGE COULD HAVE BEEN CAUSED BY THE CUMULATIVE STRESSES OF IMPACT AND TEMPERATURE CYCLING DURING AUTOCLAVING. 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. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2011. UPON REMOVAL OF THE TRIAL LINER FOLLOWING A TRIAL REDUCTION, SURGEON DISCOVERED THAT THE SCREW AND CLIP HAD DISASSOCIATED. SURGEON ALSO DISCOVERED THAT THE TRIAL LINER WAS FRACTURING. THE SURGERY WAS COMPLETED WITH NO INJURY TO THE PATIENT OR DELAY IN THE PROCEDURE. NO FOREIGN BODIES WERE RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC + MAXROM TRIAL LINER SIZE 24 X 32 MM I.D. DEVICE, PROSTHESIS ALIGNMENT IQO BIOMET ORTHOPEDICS N/A 21443132

    Patients

    Seq Age Sex Outcome Treatment
    1