BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR ARTHRODESIS NAIL 0 DEGREE COLLAR ASSEMBLY W/ LOCKING BOLTS

    MDR report key: 1972824 · Received January 28, 2011

    Report

    Report Number
    1825034-2011-00056
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 3, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    K042409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED SUGGESTS THAT THE SCREWS MAY NOT HAVE BEEN TIGHTLY SECURED DURING THE INITIAL PROCEDURE. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: POSSIBLE ADVERSE EFFECT #4 - "LOOSENING, MIGRATION AND/OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MISALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY." 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 FILED ON (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHRODESIS PROCEDURE ON (B)(6), 2010. SUBSEQUENTLY, THE MODULAR ARTHRODESIS CONSTRUCT LOOSENED APPROXIMATELY A MONTH AFTER SURGERY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 TO REMOVE AND REPLACE A MODULAR ARTHRODESIS NAIL. ALL BOLTS WERE NOTED TO BE LOOSE PRIOR TO REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHRODESIS PROCEDURE ON (B)(6), 2010. SUBSEQUENTLY, THE MODULAR ARTHRODESIS CONSTRUCT LOOSENED APPROXIMATELY A MONTH AFTER SURGERY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 TO REMOVE AND REPLACE A MODULAR ARTHRODESIS NAIL. ALL BOLTS WERE NOTED TO BE LOOSE PRIOR TO REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHRODESIS PROCEDURE ON (B)(6), 2010. SUBSEQUENTLY, THE MODULAR ARTHRODESIS CONSTRUCT LOOSENED APPROXIMATELY A MONTH AFTER SURGERY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 TO REMOVE AND REPLACE A MODULAR ARTHRODESIS NAIL. ALL BOLTS WERE NOTED TO BE LOOSE PRIOR TO REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ARTHRODESIS NAIL 0 DEGREE COLLAR ASSEMBLY W/ LOCKING BOLTS ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A 790530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R