BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 9699672 · Received February 12, 2020

    Report

    Report Number
    1038671-2020-00063
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    May 15, 2014
    Report Date
    May 26, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862061768
    PMA / PMN Number
    K032606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS 82 Y/O, 163 CM, 75 KG (BMI=28), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE R KNEE VIA MEDIAL PARAPATELLAR APPROACH ON 12/13/2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE4 RIGHT (CATALOG 230-03-04, SERIAL 1790192), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 4F/3T (CATALOG 200-04-43, SERIAL (B)(6) ), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 4 - 9MM (CATALOG 200-24-09, SERIAL (B)(6) ), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(6) ). ON (B)(6) 2014, APPROXIMATELY 41 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. THE EXACTECH DEVICES WERE REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION REPRESENTS 1 OF 163 EVENTS IDENTIFIED VIA ACTIVE SURVEILLANCE ACTIVITIES UTILIZING DATA FORM THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR). 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. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, 163 CM, (B)(6) KG (BMI=28), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE R KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE4 RIGHT (CATALOG 230-03-04, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 4F/3T (CATALOG 200-04-43, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 4 - 9MM (CATALOG 200-24-09, SERIAL (B)(4), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4). ON (B)(6) 2014, APPROXIMATELY 41 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. THE EXACTECH WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166379 OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4, JWH EXACTECH, INC. 230-03-04 UNK 10885862061768

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R