BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD PS OPEN BOX FEMORAL 60MM RIGHT INTERLOK

    MDR report key: 1943038 · Received December 30, 2010

    Report

    Report Number
    1825034-2010-00691
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATERIAL FOUND INSIDE THE PACKAGE WAS SENT TO AN OUTSIDE LAB FOR EVALUATION. THE RESULTS OF THE EVALUATION WERE RELAYED ON (B)(6) 2010, AT WHICH TIME THE EVENT WAS RECONSIDERED AS A REPORTABLE MALFUNCTION. EVALUATION OF THE FOREIGN MATERIAL SUGGESTED THAT IT WAS A MIXTURE OF POLISHING MATERIAL AND METAL DEBRIS FROM THE IMPLANT. DATE OF EVENT - UNKNOWN. THIS REPORT FILED DECEMBER 30, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SURGEON OPENED THE BOX FOR THE FEMORAL COMPONENT AND NOTICED THAT THE IMPLANT PACKAGE HAD FOREIGN BLACK MATERIAL INSIDE. ANOTHER FEMORAL COMPONENT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY. THERE WAS NO INJURY TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD PS OPEN BOX FEMORAL 60MM RIGHT INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 242060

    Patients

    Seq Age Sex Outcome Treatment
    1