BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK PSC TIBIAL BEARING 18X79/83

    MDR report key: 4120638 · Received September 26, 2014

    Report

    Report Number
    0001825034-2014-07875
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 18, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. 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.¿ THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06171, 07867, 07874 & 07875).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO INFECTION AND ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. A RE-IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2012. ADDITIONAL INFORMATION PROVIDED INDICATES THAT REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2013 TO REMOVE AND REPLACE THE POLYETHYLENE TIBIAL BEARINGS DUE TO UNKNOWN REASONS. A FURTHER REVISION PROCEDURE OCCURRED ON (B)(6) 2014 WHERE ALL COMPONENTS WERE REMOVED AND REPLACED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600546 VANGUARD SSK PSC TIBIAL BEARING 18X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 765450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R