BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEM PEGS SET 2

    MDR report key: 4200741 · Received October 24, 2014

    Report

    Report Number
    0001825034-2014-08181
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    P183099
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 2 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014- 08180 / 08184). THE REVISION PROCEDURE THAT OCCURRED ON SEPTEMBER 9, 2014 WAS REPORTED ON MANUFACTURER REPORT NUMBER 1825034-2014-07936.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. THE POLY BEARING WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT REVISION ON (B)(6) 2014 DUE TO INFECTION AND ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679968 VANGUARD FEM PEGS SET 2 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 422490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R