BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC + HI-WALL TRIAL LINER 3/8" SCREW SIZE 25 X 44MM I.D.

    MDR report key: 2241527 · Received September 9, 2011

    Report

    Report Number
    1825034-2011-00800
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 16, 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. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT SUGGESTS THE SCREW WAS OVER-TORQUED INTO THE CUP. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4) 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 ON (B)(6) 2011. DURING TRIALING, THE SURGEON NOTICED THAT THE SCREW HAD FRACTURED FROM THE TRIAL LINER. THE TRIAL LINER AND SCREW WERE REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC + HI-WALL TRIAL LINER 3/8" SCREW SIZE 25 X 44MM I.D. DEVICE, PROSTHESIS ALIGNMENT IQO BIOMET ORTHOPEDICS N/A 484703

    Patients

    Seq Age Sex Outcome Treatment
    1