BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 R FEM 75MM

    MDR report key: 3971305 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06686
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 22, 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
    US
    Reporter Occupation
    PATIENT

    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 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. PATIENT BEGAN EXPERIENCING PAIN AND SUBSEQUENT RADIOGRAPHS REVEALED A LOOSE SCREW. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE (B)(6) 2013 REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY IN 1999. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. PATIENT BEGAN EXPERIENCING PAIN AND SUBSEQUENT RADIOGRAPHS REVEALED A LOOSE SCREW. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014. THE FEMORAL SCREW WAS RETIGHTENED AND THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE REVISION PROCEDURES ON (B)(6) 2013 AND (B)(6) 2014. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446967 VNGD SSK 360 R FEM 75MM SCREW, FIXATION JWH BIOMET ORTHOPEDICS N/A 2540893

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R