BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED STEM 22 X 80MM WITH SCREW

    MDR report key: 2160038 · Received July 13, 2011

    Report

    Report Number
    1825034-2011-00558
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE TIBIAL TRAY AND BEARING REMOVED ON (B)(6) 2011, WERE MANUFACTURED BY BIOMET (B)(4). 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, (B)(4) STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY." (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND NO SIGNIFICANT MECHANICAL DAMAGE, BUT THERE WAS APPARENT LOOSENESS AT THE TAPER JUNCTION BETWEEN THIS COMPONENTS AND THE ASSOCIATED TIBIAL TRAY. THE LOOSENING BETWEEN THESE COMPONENTS IS MOST LIKELY A RESULT OF AN INSUFFICIENT OR IMPROPER IMPACTING OF THE TAPERS. THE PURPOSE OF THE STEM IS TO PROVIDE DIAPHYSEAL SUPPORT TO THE TRAY CONSTRUCT. IF THE COMPONENTS DISASSOCIATE IN VIVO, IT IS LIKELY THAT THIS WOULD CONTRIBUTE TO LOOSENING OF THE TRAY. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011, DUE TO PAIN. IT WAS FURTHER REPORTED THAT THE FEMORAL STEM WAS LOOSE AND EASILY REMOVED. THE CONNECTION BETWEEN THE TIBIAL TRAY AND STEM WAS ALSO LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SPLINED STEM 22 X 80MM WITH SCREW PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 432160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R