BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 19651654 · Received July 1, 2024

    Report

    Report Number
    1038671-2024-02244
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 02-010-04-0230 - LOGIC CR FEMORAL POR, LEFT, SZ 3 (B)(6) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS (B)(6) - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF INFECTION, COMPONENT LOOSENING, AND PROSTHESIS WEAR. HOWEVER, THE REPORTED WEAR OF THE PATELLA COULD NOT BE CONFIRMED. THE REPORTED CELLULITIS MAY HAVE LED TO THE INFECTION OF THE PATIENT¿S KNEE, RESULTING IN LOOSENING AND SUBSEQUENT THIRD BODY WEAR; HOWEVER, THE SEQUENCE OF EVENTS AND THE LIKELY CAUSE OF THE INFECTION, LOOSENING, AND INSERT WEAR COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. H6: HEALTH EFFECT-CLINICAL CODE, COMPONENT CODE, INVESTIGATION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 42 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLAR COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE. IMAGES, X-RAYS AND EBI ATTACHED. PRODUCT NOT RETURNING: DISCARDED AT HOSPITAL. PRODUCT: 02-012-51-3009 - LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM. SERIAL: (B)(6). *SERIAL NUMBER (B)(6) IS AFFECTED BY RECALL* UDI: (B)(4). 510K: K123342 PRODUCT CODE: JWH PRODUCT: 200-02-35 - THREE PEG PATELLA 35MM SERIAL: (B)(6). UDI: (B)(4). 510K: K932690. PRODUCT CODE: JWH. CONCOMITANTS: (B)(6) 02-010-04-0230 - LOGIC CR FEMORAL POR, LEFT, SZ 3 (B)(6) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS (B)(6) - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    EVERYTHING WAS REVISED. LEGAL NOTIFICATION RECEIVED. CLINICAL DETAILS: INITIAL LEFT TKR (B)(6) 2021. KNOWN POLY OXIDATION RISK, POPLITEAL CYST, SYNOVITIS. HAD SIGNIFICANT EPISODE OF CELLULITIS IN 2023 REQUIRING INTRAVENOUS ANTIBIOTICS. POSSIBLE SOURCE OF INOCULATION. CLINICALLY INFECTED TKR. ELEVATED CRP, WARM SWOLLEN, PAINFUL AND POSITIVE BONE SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565686 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention SEE H11