BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2170223 · Received July 5, 2011

    Report

    Report Number
    1644408-2011-00386
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT PRESENTED WITH KNEE PAIN. IT WAS DETERMINED A SMALLER PATELLA WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE POLY PATELLA JWH ENCORE MEDICAL, L.P. 53940956

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 385-11-506, LOT 53919962| 323-01-108, LOT 53935025| 201-01-108, LOT 53917064