BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT THN 31 3 PEG

    MDR report key: 2810081 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02266
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT OSS KNEE PROCEDURE (B)(6) 2010. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT REVISION PROCEDURE TO IMPLANT THE PATELLA BUTTON ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS AGAIN REVISED ON (B)(6) 2012 TO REMOVE AND REPLACE THE PATELLA BUTTON DUE TO MALTRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES A PAT THN 31 3 PEG PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 507790

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R