BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2931618 · Received January 22, 2013

    Report

    Report Number
    1644408-2013-00012
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    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 IDENTIFIED AS EXCESSIVE WEAR AFTER 11 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 (B)(4) SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FOURTH COMPLAINT FOR THIS PART NUMBER: TWO DUE TO WEAR, ONE PACKAGING ISSUE, AND ONE DUE TO INFECTION. THE ROOT CAUSE FOR THE REVISION SURGERY WAS DUE TO EXCESSIVE WEAR. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. 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 HAD BILATERAL KNEES IMPLANTED IN (B)(6) 2002. THE SIZE 8X9 ULTRA-CONGRUENT TIBIAL INSERTS WERE WORN DUE TO NORMAL PT WEAR, CAUSING SOME INSTABILITY. A BILATERAL TIBIAL INSERT EXCHANGE WAS PERFORMED TO A 8X11 ULTRA-CONGRUENT INSERT. THIS REPORT PERTAINS TO THE RIGHT KNEE. THERE WILL BE A SEPARATE REPORT SUBMITTED FOR THE LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30967 FOUNDATION KNEE ULTRA-CONGRUENT INSERT W/LOCKING SCREW JWH ENCORE MEDICAL, L.P. 762191

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention