BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD KNEE

    MDR report key: 4251790 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08637
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    February 6, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND RECEIVED A VANGUARD KNEE. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ALLERGIC REACTION. IT IS UNKNOWN IF THE IMPLANTS CAUSED THE REACTION. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738333 UNKNOWN VANGUARD KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other