BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2851091 · Received November 19, 2012

    Report

    Report Number
    1644408-2012-00625
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 AN AGENT INFORMED DJO SURGICAL OF A PRODUCT COMPLAINT INVOLVING A INSERT, CONSTRAINED, P.S., SIZE 6 17MM. A PRIMARY SURGERY WAS PERFORMED ON (B)(4) 2008 AND THE REVISION ON (B)(4) 2012. THE POSTERIOR POST WAS REPORTED TO HAVE BROKEN DUE TO TRAUMA AFTER 3 YEARS 11 MONTHS OF PATIENT USE. THERE WAS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE TIBIAL INSERT POST FRACTURE. 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 ROOT CAUSE FOR THIS REVISION SURGERY COULD NOT BE DETERMINED WITH CONFIDENCE SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION. 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 AND BROKE THE POSTERIOR STABILIZED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE CONSTRAINED REVISION PS INSERT 17MM CM JWH ENCORE MEDICAL, L.P. 900201

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention