BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BRNG12X71/75MM

    MDR report key: 3162426 · Received June 11, 2013

    Report

    Report Number
    0001825034-2013-01899
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY, RIGHT IN 1997 AND THE LEFT (B)(6) 2003. SUBSEQUENTLY, PATIENT ALLEGES STIFFNESS, ACHES AND AUDIBLE NOISE IN HER RIGHT KNEE. A RIGHT REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO POLY WEAR. THE BEARING, TIBIAL TRAY, FEMORAL AND PATELLA COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262805 MAX PRI DCM TIB BRNG12X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R