BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIH MODULAR CUP INSERTER

    MDR report key: 1790577 · Received August 10, 2010

    Report

    Report Number
    1825034-2010-00315
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT HAD NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE INSTRUMENT FOUND THAT IT APPEARED TO BE MANUFACTURED CORRECTLY AND USED CORRECTLY. THE INSTRUMENT WAS USED BY A VERY HIGH VOLUME SURGEON FOR THE LAST THREE YEARS AND SHOWS SIGNS THAT IT HAS BEEN USED MANY TIMES. IT IS POSSIBLE THAT AFTER THREE YEARS OF EXTREME USE, THE HANDLE REACHED THE FATIGUE LIMIT AND BROKE. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A MODULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE CUP INSERTER BROKE WHILE THE DOCTOR WAS IMPACTING THE CUP. ANOTHER CUP INSERTER WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY OR INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A MODULAR CUP INSERTER ON (B)(6) 2010. DURING THE PROCEDURE, THE CUP INSERTER BROKE WHILE THE DOCTOR WAS IMPACTING THE CUP. ANOTHER CUP INSERTER WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIH MODULAR CUP INSERTER ORTHO, MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 241040

    Patients

    Seq Age Sex Outcome Treatment
    1