BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER

    MDR report key: 1030349 · Received April 15, 2008

    Report

    Report Number
    1825034-2008-00106
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2008-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED ON APRIL 15, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT STAGE 2 REVISION OF THE ACETABULUM IN 2008. DURING PROCEDURE, SURGEON ENCOUNTERED DIFFICULTY WHILE TRYING TO REMOVE THE INSERTER FROM THE SHELL IMPLANT. ONCE INSTRUMENT WAS REMOVED, THE SURGEON ATTEMPTED TO INSERT A DIFFERENT SHELL AND ONCE AGAIN ENCOUNTERED THE SAME DIFFICULTY WHILE TRYING TO REMOVE INSTRUMENT FROM SHELL IMPLANT. A 15-20 MINUTE DELAY IN PROCEDURE WAS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR MICROPLASTY CUP INSERTER LXH BIOMET, INC. NA 240920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other