BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAK OSS LOCK PIN NO HEAD / WITH PLUG

    MDR report key: 2233754 · Received September 3, 2011

    Report

    Report Number
    1825034-2011-00783
    Event Type
    Injury
    Date Received
    September 3, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    K083779
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, AND/OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 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 (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHROPLASTY PROCEDURE ON (B)(6), 2010. SUBSEQUENTLY, RADIOGRAPHS TAKEN ON (B)(6), 2011, SHOWED THAT THE FEMORAL LOCKING PIN HAD BACKED OUT AND WAS FLOATING IN THE PATIENT'S SOFT TISSUE. THE PATIENT HAS REPORTED NO PAIN OR LOSS OF FUNCTION. AS OF THIS DATE, NO REVISION PROCEDURE HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAK OSS LOCK PIN NO HEAD / WITH PLUG PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 750120

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S