BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 3131131 · Received May 23, 2013

    Report

    Report Number
    1644408-2013-00295
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    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 REPORTED AS THE PATIENT WAS EXPERIENCING INSTABILITY AFTER 6.7 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE WAS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S INSTABILITY. 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 NOT RETURNED TO DJO 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: ONE FOR STABILITY/POOR JOINT ISSUES, TWO CRACKED/BROKEN DEVICES, AND ONE DUE TO PAIN. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE INSTABILITY WAS NOT DETERMINED WITH CONFIDENCE. 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 NEEDED MORE CONSTRAINT, SO A CONSTRAINED LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229638 FOUNDATION KNEE PS INSERT 19MM CM JWH ENCORE MEDICAL, L.P. 53955190

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention