BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 71MM

    MDR report key: 6345223 · Received February 21, 2017

    Report

    Report Number
    0001825034-2017-00333
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    September 30, 2014
    Report Date
    February 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT INITIALLY REPORTED ON MANUFACTURING REPORT NUMBER 1822565-2016-00877. TIBIAL BEARING - CATALOGUE 183640 LOT 073710. FEMORAL - CATALOGUE 183126 LOT 301730. THIS DEVICE IS USED FOR TREATMENT. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED LEFT KNEE PAIN, CRUNCHING AND POPPING NOISES, AND LIMITED RANGE OF MOTION TWO YEARS POST IMPLANTATION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127624 BIOMET CC I-BEAM TRAY 71MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J3351408

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SEE H10