BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM INTRIK TIBIAL PLATE

    MDR report key: 1051630 · Received May 22, 2008

    Report

    Report Number
    1825034-2008-00159
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATES THAT THIS TYPE OF EVENT CAN OCCUR. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. THE FOLLOWING USER FACILITY INFO IS AVAILABLE: EVAL IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVAL, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2005. SUBSEQUENTLY, LOCKING BAR BACKED OUT OF THE TIBIA COMPONENT AND REVISION PROCEDURE WAS PERFORMED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIM INTRIK TIBIAL PLATE JWH BIOMET, INC. NA 841990

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R