BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 9714897 · Received February 14, 2020

    Report

    Report Number
    1038671-2020-00198
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    August 10, 2015
    Report Date
    May 8, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862047601
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED THAT REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION. THIS SUBMISSION REPRESENTS 1 OF 163 EVENTS IDENTIFIED VIA ACTIVE SURVEILLANCE ACTIVITIES UTILIZING DATA FORM THE (B)(6).FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT AS THE INFORMATION WAS SUBMITTED AS COMPLETE BY THE REGISTRY; THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED AND IT IS NOT POSSIBLE TO OBTAIN ANY OF THE DEVICES. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, AND B6. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO: D2, D4 (CATALOG NUMBER, SERIAL NUMBER, EXP DATE, AND UDI NUMBER), G4, G5, G7, H1, H2, H3, H4, H6, AND H7. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (D2) COMMON DEVICE NAME. (D4) CATALOG NUMBER, SERIAL NUMBER, EXP DATE, AND UDI NUMBER . (G5) 510K NUMBER . (H4) MANUFACTURE DATE . (H6) EVALUATION CODES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6) REGISTRY ((B)(6)), THIS (B)(6) Y/O, 183 CM, (B)(6) KG (BMI=24), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK KNEE SYSTEM - CEMENTED POSTERIOR STABILISED (PS) FEMORAL COMPONENT - SIZE 5 (CATALOG 204-01-05, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 5F/4T (CATALOG 200-04-54, SERIAL 1462007), OPTETRAK KNEE SYSTEM - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 5 - 13MM (CATALOG 204-25-13, SERIAL 1153163) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2015, APPROXIMATELY 45 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH OPTETRAK OFFSET TIBIAL TRAY 5F/4T BETA, OPTETRAK KNEE SYSTEM - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 5 - 18MM AND OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 38MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176342 OPTETRAK CEMENTED FINNED TIB. TRA SZ 5F/4T JWH EXACTECH, INC. PS CEMENTED FEMORAL SZ 5 10885862047601

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention