BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN KNEE

    MDR report key: 2170132 · Received June 22, 2011

    Report

    Report Number
    1644408-2011-00360
    Event Type
    Other
    Date Received
    June 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K905613
    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 TO THE DOCTOR WITH A LOOSE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN KNEE TIBIA INSERT JWH ENCORE MEDICAL, L.P. 61951

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 202-01-106, LOT 70001| 304-01-104, LOT 147931| 120-01-032, LOT 149041