BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3006721341-2019-00009

    MDR report key: 8446172 · Received March 22, 2019

    Report

    Report Number
    3006721341-2019-00009
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    January 3, 2019
    Report Date
    March 4, 2019
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, LINK FEMORAL COMPONENT (PART OF 15-3816/12 ASSEMBLY), LINK FEMORAL SEGMENT (15-2973/02) AND LINK STEM (15-3950/05) LINK COMPONENTS WERE IMPLANTED DURING REVISION OF A COMPETITIVE KNEE SYSTEM. ON (B)(6) 2019, THE LINK FEMORAL COMPONENT (PART OF 15-3816/12 ASSEMBLY), LINK FEMORAL SEGMENT (15-2973/02) AND LINK STEM (15-3950/05) WERE EXPLANTED DUE TO FEMORAL COMPONENT LOOSENING. THEY WERE REPLACED WITH A DISTAL FEMORAL REPLACEMENT WITH POREX (CM000097), A REPLACEMENT SET/POREX (15-3027/11), CEMENTLESS STEM (15-8522/60), AND STEM SEGMENT (15-8522/02). NOTE: UPON REVIEW OF ORDER RECORDS ON (B)(6) 2019 RELATED TO THE REPLACEMENT COMPONENT CM000097 (IMPLANTED ON (B)(6) 2019), REVIEWER FOUND THAT LINK COMPONENTS HAD BEEN EXPLANTED DURING THE SURGERY, AND INITIATED THIS COMPLAINT FILE.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention