BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD CRL TIB BRG 63/67X10

    MDR report key: 3777722 · Received April 29, 2014

    Report

    Report Number
    0001825034-2014-03368
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EXAMINATION OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. VISUAL EXAMINATION BY THE DEVELOPMENT ENGINEER OF THE BEARING FOUND NO EVIDENCE OF WEAR. SINCE THERE IS NO EVIDENCE OF WEAR, IT IS LIKELY THAT THE INSTABILITY CAME FROM THE SOFT TISSUES IN THE KNEE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "MALALIGNMENT OR SOFT TISSUE IMBALANCE CAN PLACE INORDINATE FORCES ON THE COMPONENTS, WHICH MAY CAUSE EXCESSIVE WEAR TO THE PATELLAR OR TIBIAL BEARING ARTICULATING SURFACES. REVISION SURGERY MAY BE REQUIRED TO PREVENT COMPONENT FAILURE."

    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." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BILATERAL TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE ON (B)(6) 2014 DUE TO INSTABILITY AND GENU VALGUM. THE FEMORAL COMPONENT, TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256432 E1 VNGD CRL TIB BRG 63/67X10 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 899920

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R