BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD CR FEMORAL 60MM RIGHT INTERLOK

    MDR report key: 1882090 · Received October 25, 2010

    Report

    Report Number
    1825034-2010-00467
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPONENT WAS PART OF A THREE-PIECE (UNIT) LOT. THE OTHER TWO UNITS WERE WITHIN BIOMET'S CONTROL. THIS REPORT FILED OCTOBER 25, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY UTILIZING A VANGUARD FEMORAL COMPONENT ON (B)(6) 2010. DURING THE PROCEDURE, THE COMPONENT WAS OPENED AND THE PEGS WERE MISSING. ANOTHER FEMORAL COMPONENT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD CR FEMORAL 60MM RIGHT INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 194620

    Patients

    Seq Age Sex Outcome Treatment
    1