BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL 75MM RIGHT INTERLOK

    MDR report key: 2231809 · Received September 1, 2011

    Report

    Report Number
    1825034-2011-00762
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 POSSIBLE ADVERSE EFFECTS, NUMBER FIFTEEN STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN". THIS IS MDR ONE OF TWO (1825034-2011-00762 THROUGH 00763) FOR THIS EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    FEMORAL COMPONENT SHOWED BONE CEMENT EXTENDING INTO THE INTERCONDYLAR BOX. THE SURGICAL TECHNIQUE INSTRUCTS SURGEONS TO REMOVE EXTRUDED CEMENT WITH A CURETTE. THE EXTRUDED BONE CEMENT IMPINGED ON THE POST OF THE TIBIAL BEARING, POSSIBLY LEADING TO THE REPORTED PAIN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER SEVEN STATES, "COMPLETE PRECLOSURE CLEANING AND REMOVAL OF BONE CEMENT DEBRIS, METALLIC DEBRIS, AND OTHER SURGICAL DEBRIS AT THE IMPLANT SITE IS CRITICAL TO MINIMIZE WEAR OF THE IMPLANT ARTICULAR SURFACES". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2011, DUE TO PAIN. SURGEON NOTED SOME DISCOLORATION OF TISSUE ADJACENT TO THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD PS OPEN BOX FEMORAL 75MM RIGHT INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 609330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R