BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOVATION KNEE

    MDR report key: 4130119 · Received September 30, 2014

    Report

    Report Number
    1644408-2014-00594
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OIY
    PMA / PMN Number
    K121727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ADDRESS SCAR TISSUE ISSUE IN THE PATIENT'S JOINT AFTER 5.5 MONTHS OF USE. 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 THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 318N1000. THIS IS THE FIRST COMPLAINT FILED AGAINST THIS PART AND LOT NUMBER. THE EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE ROOT CAUSE WAS PATIENT ISSUES WITH SCAR TISSUE BUILDUP IN THE JOINT. 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 SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607265 MOVATION KNEE E-PLUS INSERT, MOVATION 13MM 6 OIY ENCORE MEDICAL, L.P. 318N1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention