BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 22458654 · Received July 9, 2025

    Report

    Report Number
    1038671-2025-02449
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 3, 2025
    Report Date
    October 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862003904
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-010-03-0220 - LOGIC FEMUR CR CEMENTADO Nº2 IZQ. (B)(6), 02-012-48-2011 - LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM. (B)(6), 200-02-29 - ROTULA TRES TETONES 29MM. (B)(6), 13-0901-27L-F1 - HALL ESTRECHA 90X13X1.27 NUEVA (V130-127-90). SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR EVALUATION; PHOTOGRAPHS OF THE DEVICE AND RADIOGRAPHS WERE PROVIDED; HOWEVER, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE REVIEW IDENTIFIED THE EXPLANTED TIBIAL INSERT APPEARS TO HAVE ISOLATED REGIONS OF WEAR DAMAGE INCLUDING PITTING, DELAMINATION, AND THIRD BODY WEAR. THE POSTEROLATERAL EDGE OF THE INSERT ALSO SHOWS FULL THICKNESS WEAR. THE WEAR DAMAGE IS ISOLATED TO THE POSTEROLATERAL AND ANTEROMEDIAL SIDES OF THE INSERT. THE TIBIAL INSERT APPEARS TO HAVE WEAR AND ON THE POSTERIOR PORTION OF THE ARTICULATING SURFACE. THIS WAS LIKELY CAUSED BY HIGH STRESS DURING KNEE FLEXION INDICATING THE KNEE WAS TIGHT IN FLEXION. THE RADIOGRAPH SHOWS AN ASYMMETRIC JOINT SPACE THAT COINCIDES WITH THE INCREASED WEAR DAMAGE ON THE LATERAL SIDE OF THE INSERT. THE JOINT TISSUE APPEARS TO BE COLORED GRAY WHICH IS CONSISTENT WITH METAL DEBRIS IN THE JOINT. THERE IS ALSO POTENTIAL CONTACT OF THE FEMORAL COMPONENT ON THE POSTERIOR REGION OF THE TIBIAL TRAY DURING EXTENSION, WHICH COULD LEAD TO METAL-ON-METAL ARTICULATION AND GENERATE METAL WEAR DEBRIS IN THE JOINT SPACE. THE ANTERIOR AND POSTERIOR SIDES OF THE DISTAL FEMORAL BONE APPEAR TO HAVE LUCENCIES BETWEEN THE ANTERIOR BONE CONTACTING SURFACE OF THE FEMORAL COMPONENT, WHICH IS CONSISTENT WITH LOOSENING. HOWEVER, THE REPORTED COMPONENT LOOSENING CAN¿T BE CONFIRMED AS RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR LEADING TO METAL-ON-METAL WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE FEMORAL LOOSENING, TIBIAL LOOSENING, AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THE REPORTED IMPLANT LOOSENING AND METALLOSIS COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 77 YO FEMALE PATIENT WHO HAD A LEFT SIDE KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THEY HAD POOR PROSTHETIC EVOLUTION FOLLOWING THE IMMEDIATE POSTOPERATIVE PERIOD, WITH PERSISTENT PAIN AND RECURRENT JOINT EFFUSION. THE PATIENT PRESENTED TO THE EMERGENCY DEPT WITH INCREASED PAIN, ALONG WITH AUDIBLE PROSTHETIC CLICKING DURING CERTAIN MOVEMENTS AND JOINT EFFUSION. X-RAY REVEALED ASYMMETRY IN THE MEDIAL AND LATERAL JOINT SPACES BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, SUGGESTIVE OF POLYETHYLENE FAILURE. A BONE SCAN CONFIRMED LOOSENING OF THE PROSTHETIC COMPONENTS. THE SURGERY PERFORMED REVEALED EXTENSIVE GRAYISH PERIPROSTHETIC MATERIAL SUGGESTIVE OF METALLOSIS. THE POLYETHYLENE WAS REMOVED, REVEALING ABNORMAL WEAR IN THE POSTERIOR-LATERAL REGION, WHICH HAD RELEASED POLYETHYLENE DEBRIS INTO THE PATIENT'S SOFT TISSUE. ALL PROSTHETIC COMPONENTS WERE REMOVED, AS WELL AS ALL TISSUE SUGGESTIVE OF METALLOSIS EXCISED, AND A REVISION TOTAL KNEE REPLACEMENT OF A COMPETITOR¿S DEVICES WERE IMPLANTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE NOT ABLE TO BE OBTAINED. IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701742 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862003904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11.