BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2648350 · Received July 3, 2012

    Report

    Report Number
    1644408-2012-00342
    Event Type
    Other
    Date Received
    July 3, 2012
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AN AGENT INFORMED DJO SURGICAL THAT A PATIENT HAD A REVISION SURGERY DUE TO A TRAUMA EVENT. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE IS NO INFORMATION PROVIDED IN THIS COMPLAINT RELATING TO PATIENT CONTRAINDICATIONS OR PHYSICAL ACTIVITY LEVEL WHICH MIGHT HAVE ALSO CONTRIBUTED TO THIS EVENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THE DEVICE HISTORY RECORD IS EVIDENCE THAT ALL COMPONENTS MET CRITICAL DIMENSIONS AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FROM DJO SURGICAL. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE ARE EIGHT PRIOR COMPLAINTS ASSOCIATED WITH THIS PART NUMBER. NO OTHER COMPLAINTS WERE IDENTIFIED INVOLVING THIS SUBJECT LOT. THE ROOT CAUSE OF THIS EVENT WAS REPORTED TO BE DISLOCATION CAUSED BY TRAUMA. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY; THE PT FELL ON THE LEFT KNEE, CAUSING JUMPING THE POST OFF THE TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE PS INSERT 11 MM CM JWH ENCORE MEDICAL, L.P. 59600058

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention