BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DKNEE

    MDR report key: 4182258 · Received October 17, 2014

    Report

    Report Number
    1644408-2014-00648
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ALLEVIATE INSTABILITY IN THE PATIENT'S KNEE AFTER 6.8 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED 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 AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE MAIN CONTRIBUTOR COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 538671321. A TOTAL OF SIX COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER. THIS IS THE SECOND COMPLAINT FOR INSTABILITY. THE REMAINING COMPLAINTS HAVE RESULTED FROM OTHER ISSUES SUCH AS INFECTIONS AND INSTABILITY. THE PATIENT IS REPORTED TO HAVE HAD INSTABILITY IN THE KNEE BUT NO FURTHER EXPLANATION WAS OFFERED INDICATING THE ROOT CAUSE OR REASON FOR THE INSTABILITY. FACTORS UN-RELATED TO THE IMPLANTS THAT MAY CONTRIBUTE TO A PATIENT INSTABILITY ARE: DEGENERATIVE BONE, IMPROPER OR INCORRECT IMPLANT SELECTION. 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 KNEE INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662302 3DKNEE 3D NON-POROUS FEMUR 8 LEFT JWH ENCORE MEDICAL, L.P. 53867132

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 391-09-608, LOT 53881740