BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MJS POSTERIOR STABILIZED KNEE

    MDR report key: 6623678 · Received June 8, 2017

    Report

    Report Number
    1644408-2017-00437
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 10, 2017
    Report Date
    August 1, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HRY
    UDI-DI
    00888912121491
    PMA / PMN Number
    K012762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS POLY EXCHANGE AND THE POLY HAS EVIDENCE OF SOME WEAR. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT IS UNKNOWN SINCE THE PRIMARY DATE WAS NOT PROVIDED OR DETERMINED. 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. THERE ARE NO REPORTED PRE-EXISTING PATIENT HEALTH CONDITIONS. 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. REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT CONDUCTED FOR THE EXPLANTED PART (S) SINCE THE LOT NUMBER WAS NOT SUPPLIED OR DETERMINED. THE COMPLAINT INVESTIGATION HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS COMPLAINT WILL BE CLOSED WITHOUT A LOT NUMBER. SHOULD A LOT NUMBER BECOME AVAILABLE THE COMPLAINT WILL BE REOPENED AND A FURTHER ASSESSMENT MADE. THIS EVENT IS DEEMED AS NON-PRODUCT RELATED. THE ROOT CAUSE FOR THIS EVENT WAS THE PATIENT HAD A POLY EXCHANGE AND THE POLY HAS EVIDENCE OF SOME WEAR. THE ROOT CAUSE FOR THE POLY EXCHANGE AND WEAR WAS NOT REPORTED. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE EXPLANTED PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE 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 A POLY EXCHANGE; THE SURGEON NOTED THAT THERE WAS SOME WEAR ON THE POLY. I AM NOT SURE WHAT THE PRIMARY DATE OF SURGERY WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409536 MJS POSTERIOR STABILIZED KNEE INSERT, TIBIAL, S #2 MJS KNEE HRY ENCORE MEDICAL, L.P. 00888912121491

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention