BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 83MM

    MDR report key: 3071388 · Received April 22, 2013

    Report

    Report Number
    0001825034-2013-01101
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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 PATIENT UNDERWENT A KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN. THE TIBIA TRAY AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173040 BIOMET CC CRUCIATE TRAY 83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R