BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3013375 · Received March 20, 2013

    Report

    Report Number
    1644408-2013-00166
    Date Received
    March 20, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY PAIN AFTER 6.8 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. 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. (B)(4). THE ROOT CAUSE OF THE PAIN WAS NOT DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PATIENT WAS EXPERIENCING PAIN IN HIS LEFT KNEE. HE HAD A PREVIOUS POLY EXCHANGE ON (B)(6) 2006. THE INSERT WAS FOUND TO HAVE NORMAL WEAR AND THE SURGEON CLEANED UP SOME DEBRIS IN THE KNEE AND CHANGED THE TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115518 FOUNDATION KNEE PS INSERT 19MM CM JWH ENCORE MEDICAL, L.P. 965681

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention