BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC KNEE

    MDR report key: 6067572 · Received October 31, 2016

    Report

    Report Number
    0001825034-2016-04322
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 7, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE 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, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY NINE YEARS POST IMPLANTATION DUE TO PAIN. THE TIBIAL BEARING, TIBIAL COMPONENT, LOCKING BAR AND PATELLA BUTTON WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719625 UNKNOWN AGC KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R