BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER

    MDR report key: 1910876 · Received November 30, 2010

    Report

    Report Number
    1825034-2010-00630
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE WAS DISASSEMBLED AND DIMENSIONALLY EVALUATED; EVALUATION DID NOT IDENTIFY ANY PRODUCT NON-CONFORMANCE. DEVICE WAS REASSEMBLED AND FUNCTIONED AS INTENDED. THIS REPORT FILED JANUARY 5, 2011.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT SUBMITTED NOVEMBER 30, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP PROCEDURE UTILIZING A MODULAR MICROPLASTY CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE THREADED INSERT TIP WAS NOT WORKING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP PROCEDURE UTILIZING A MODULAR MICROPLASTY CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE THREADED INSERT TIP WAS NOT WORKING CORRECTLY. 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 MODULAR MICROPLASTY CUP INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 025440

    Patients

    Seq Age Sex Outcome Treatment
    1