BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1061736 · Received June 16, 2008

    Report

    Report Number
    1644408-2008-00182
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO RECEIVED. ENCORE WILL CONTINUE TO RESEARCH THE COMPLAINT AND WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY-KNEE WAS INFECTED AND SURGEON DID A POLY SWAP. ORIGINAL SURGERY DATE OF THE PROCEDURE IS UNKNOWN, APPROX 13 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NONE HRY ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention