BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 3161886 · Received June 6, 2013

    Report

    Report Number
    1644408-2013-00317
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    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 REPORTED AS THE PATIENT WAS UNABLE TO OBTAIN FULL EXTENSION OF THE KNEE AFTER 5.5 MONTHS 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 NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED TWO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT: NCMR #14590 INVOLVED TWO PARTS THAT WERE RETURNED TO THE VENDOR FOR UNDERSIZED FEATURES AND NCMR #15358 INVOLVED ONE PART THAT WAS SCRAPPED FOR TOOL MARKS ON THE SURFACE FINISH. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 17TH COMPLAINT FOR THIS PRODUCT: FIVE REVISION SURGERIES, TWO DUE TO WEAR/EXCESSIVE WEAR, TWO DUE TO PAIN, TWO DUE TO INFECTION, ONE DUE TO TRAUMA, AND FIVE FOR STABILITY/POOR JOINT ISSUES. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THIS REVISION WAS MOST LIKELY DUE TO FLEXION CONTRACTURE. 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 FLEXION CONTRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251785 3DKNEE DCM INSERT, 9MM JWH ENCORE MEDICAL, L.P. 59600897

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention