BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 R FEM 65MM

    MDR report key: 3914420 · Received July 3, 2014

    Report

    Report Number
    3002806535-2014-00166
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    October 17, 2012
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 2 OF 9 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-03192 AND 2014-05976 / 05981 AND 05983 AND 3002806535-2014-00166).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT UNDERWENT A REVISION ON (B)(6) 2010 DUE TO INFECTION. SUBSEQUENTLY, PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2010. PATIENT UNDERWENT MANIPULATION ON (B)(6) 2010 DUE TO ARTHROFIBROSIS. IT WAS FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2011 DUE TO SEPSIS. PATIENT WAS REIMPLANTED ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A MANIPULATION ON (B)(6) 2012 DUE TO PAIN AND LACK OF RANGE OF MOTION. IT WAS NOTED IN MEDICAL RECORDS THEY WERE UNABLE TO COMPLETE THE MANIPULATION DUE TO SCARRING TISSUE. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO INFECTION. PATIENT WAS REIMPLANTED ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389859 VNGD SSK 360 R FEM 65MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2285545

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R