BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DKNEE

    MDR report key: 6004885 · Received October 6, 2016

    Report

    Report Number
    1644408-2016-00739
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OIY
    UDI-DI
    00888912120265
    PMA / PMN Number
    K091956
    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 THE PATIENT HAD BECOME UNSTABLE. THE IN-VIVO LENGTH OF SERVICE FOR THE PATIENT'S IMPLANT WAS 1.2 YEARS. 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 A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. INITIAL OR PROLONGED HOSPITALIZATION WAS REQUIRED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE INSTABILITY WAS NOT REPORTED. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS, ROOT CAUSE, RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED AS 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 THE PATIENT HAVING BECOME UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656968 3DKNEE INSERT, 3D EX SZ 6RT 9MM OIY ENCORE MEDICAL, L.P. 328G1056 00888912120265

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O| R (B)(4)