BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, KNEE

    MDR report key: 3232075 · Received July 17, 2013

    Report

    Report Number
    0001825034-2013-02738
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. BRAND NAME ¿ UNKNOWN. DEVICE PRODUCT CODE - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. THE SURGEON REMOVED THE KNEE COMPONENTS AND IMPLANTED CEMENT SPACER MOLDS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330473 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R