BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X79/83

    MDR report key: 4130427 · Received September 30, 2014

    Report

    Report Number
    0001825034-2014-07904
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Description of Event or Problem · 1

    PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A BEARING EXCHANGE AND WASHOUT ON (B)(6) 2014 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609438 VNGD CR TIB BRG 10X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 059460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R