BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINNED 1 PIECE TIBIAL TRAY

    MDR report key: 2010786 · Received March 2, 2011

    Report

    Report Number
    9610576-2011-00003
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BIOMET SPAIN S.L.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    NA
    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ITEM TO BE RETURNED TO MANUFACTURER. UPON RECEIPT OF COMPONENT AND COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED ON (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2010. PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2011 DUE TO POSSIBLE INFECTION AND LOOSENING OF THE TIBIAL COMPONENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINNED 1 PIECE TIBIAL TRAY JWH BIOMET SPAIN S.L. NA 2009110789

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R