BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 79MM

    MDR report key: 4151264 · Received October 8, 2014

    Report

    Report Number
    0001825034-2014-08050
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE ¿ 12/2013. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014- 08049).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO LOOSENING AND PAIN AS A RESULT OF BENDING THE KNEE TOO MUCH. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633097 BIOMET CC CRUCIATE TRAY 79MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J2383944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R