BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1943851 · Received December 22, 2010

    Report

    Report Number
    1644408-2010-00687
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS EXPERIENCING PAIN AT THE WOUND FROM THE FIRST REVISION SURGERY ON (B)(6) 2010. THE DOCTOR DECIDED TO PERFORM AN I&D WITH POLY SWAP. THE WOUND WAS THOROUGHLY WASHED OUT AND THE TIBIAL INSERT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 483121

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention