BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC + HI-WALL TRIAL LINER

    MDR report key: 2172132 · Received July 22, 2011

    Report

    Report Number
    1825034-2011-00583
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE TRIAL ACETABULAR LINER APPEARS TO HAVE FAILED DUE TO PUSH-OUT OVERLOAD OF THE FASTENER THROUGH THE APICAL HOLE. 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 REVISION PROCEDURE TO REMOVE COMPETITOR PRODUCT ON (B)(6) 2011. DURING THE PROCEDURE, AFTER TRIALING, THE SURGEON NOTED THAT THE TRIAL LINER HAD SEPARATED FROM THE SCREW PORTION OF THE LINER AND REMAINED IN THE ACETABULAR CUP. THE SURGEON REMOVED THE SCREW FROM THE BOTTOM OF THE CUP AND CONTINUED WITH THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT OR DELAY IN THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC + HI-WALL TRIAL LINER DEVICE, PROSTHESIS ALIGNMENT IQO BIOMET ORTHOPEDICS N/A 677920

    Patients

    Seq Age Sex Outcome Treatment
    1