BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER 3/8"

    MDR report key: 1963084 · Received January 18, 2011

    Report

    Report Number
    1825034-2011-00044
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FRACTURE SURFACE OF THE LOCK BODY SHOWS CONCENTRIC PROGRESSION MARKS SURROUNDING A SMALL INSTANTANEOUS ZONE THAT IS CONSISTENT WITH A ROTATING FATIGUE FAILURE. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 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. THIS REPORT SUBMITTED JANUARY 18, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, WHILE THE SURGEON WAS UNSCREWING THE IMPACTOR, THE LOCKING MECHANISM FRACTURED. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT NOR A DELAY IN THE SURGERY. RADIOGRAPHS CONFIRMED THAT NO FOREIGN BODY WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR MICROPLASTY CUP INSERTER 3/8" ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 131480

    Patients

    Seq Age Sex Outcome Treatment
    1