BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3061753 · Received April 16, 2013

    Report

    Report Number
    1644408-2013-00215
    Date Received
    April 16, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY JOINT INSTABILITY AND PAIN AFTER 3.1 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 DISPOSED OF BY THE HOSPITAL AND WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT SHOWS THIS IS THE SIXTH COMPLAINT FOR THIS PART NUMBER: THREE DUE TO INFECTION, ONE DUE TO PAIN, AND TWO FOR INSTABILITY. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE INSTABILITY AND 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

    REVISION SURGERY - DUE TO INSTABILITY AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162362 FOUNDATION KNEE ALL-POLY SOMBRERO TRI-PEG PATELLA JWH ENCORE MEDICAL, L.P. 53986031

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Congenital Anomaly| R (B)(4), LOT 54035095