BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3013471 · Received March 20, 2013

    Report

    Report Number
    1644408-2013-00168
    Date Received
    March 20, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY PATIENT INSTABILITY AFTER 5.6 YEARS OF PATIENT USE. 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 FOR THE INSTABILITY WAS MOST LIKELY DUE TO THE POLYETHYLENE INSERT BEING WORN DOWN ON THE POSTERIOR SIDE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT WAS UNSTABLE AND THE POLYETHYLENE WAS WORN DOWN ON THE POSTERIOR SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115200 FOUNDATION KNEE PRIMARY INSERT 13MM CM JWH ENCORE MEDICAL, L.P. 888311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4), LOT 856921| (B)(4), LOT 53838592| (B)(4), LOT 53862468