BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD

    MDR report key: 1933400 · Received December 20, 2010

    Report

    Report Number
    1825034-2010-00668
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE WAS INCONCLUSIVE AS THE COMPONENTS THAT FRACTURED WERE NOT RETURNED FOR EVALUATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. 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 DECEMBER 20, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY UTILIZING A CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, A PORTION OF THE CUP INSERTER FRACTURED. THE SURGEON RETRIEVED THE FRACTURED PIECE AND COMPLETED THE SURGERY WITHOUT INJURY TO THE PATIENT OR SIGNIFICANT DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 666900

    Patients

    Seq Age Sex Outcome Treatment
    1