BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 19645140 · Received July 1, 2024

    Report

    Report Number
    1038671-2024-02226
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 12, 2024
    Report Date
    November 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S RT KNEE REVISION ON 4/10/2024 REPORTED UNDER 1038671-2020-00545 D10: CONCOMITANT DEVICES: 5935891 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5. 4049161 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T. 5836894 200-02-38 - THREE PEG PATELLA 38MM. 6298319 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 6005587 201-78-81 - 3 TROCAR, MOD. HEX 2PK. S018345 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S049106 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S064307 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 01000320008 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    CORRECTION: PATIENT'S RT KNEE REVISION ON (B)(6) 2024 REPORTED UNDER 1038671-2020-00545 SHOULD BE "PATIENT'S LEFT KNEE REVISION ON (B)(6) 2020." ADDITIONAL INFORMATION: H3 - ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY IN (B)(6) 2020. APPROXIMATELY 2 WEEKS LATER, ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY. THE LINER WAS REPLACED. APPROXIMATELY 3 YEARS AND 10 MONTHS LATER, ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO PROSTHESIS WEAR. COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6 - COMPONENT CODE AND INVESTIGATION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE LINER WAS REPLACED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE CUSTOMER. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565206 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention SEE H11.