BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SPLINED KNEE STM 16X120

    MDR report key: 3914431 · Received July 3, 2014

    Report

    Report Number
    0001825034-2014-05980
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    October 17, 2012
    Report Date
    January 21, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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 WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 8 OF 9 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-03192 & 2014-05976 / 05981 & 05983 & 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.

    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 NOVEMBER 30, 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. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REIMPLANTED ON (B)(6) 2013. PATIENT UNDERWENT A FURTHER REVISION ON (B)(6) 2014 DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390767 BMT SPLINED KNEE STM 16X120 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 979680

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R